U.S. patent number 7,959,860 [Application Number 11/350,363] was granted by the patent office on 2011-06-14 for system and method of detecting fluid and leaks in thermal treatment system basins.
Invention is credited to Calvin Blankenship, Durward I. Faries, Jr., David Hendrix, Bruce R. Heymann.
United States Patent |
7,959,860 |
Faries, Jr. , et
al. |
June 14, 2011 |
System and method of detecting fluid and leaks in thermal treatment
system basins
Abstract
A drape including a sensing device according to the present
invention is disposed over a top surface of a thermal treatment
system having a basin recessed therein. A portion of the drape is
pushed down into the basin to form a drape container for collecting
a sterile medium. The thermal treatment system may be of the type
that either heats or congeals the sterile medium. The sensing
device includes electrodes that are typically disposed through the
drape and sealed. The electrodes provide signals indicating the
presence of liquid and/or leaks or other conditions within the
drape container to the system to facilitate control of system
operation. In addition, the sensing device includes a fuse to limit
the drape to a single use. The system disables the fuse to indicate
prior use and detects tampering to bypass the fuse, thereby
preventing use of the drape for subsequent medical procedures.
Inventors: |
Faries, Jr.; Durward I. (Las
Vegas, NV), Heymann; Bruce R. (Vienna, VA), Blankenship;
Calvin (Frostburg, MD), Hendrix; David (Ashburn,
VA) |
Family
ID: |
38345825 |
Appl.
No.: |
11/350,363 |
Filed: |
February 9, 2006 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20060194324 A1 |
Aug 31, 2006 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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10836236 |
May 3, 2004 |
7347210 |
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10372674 |
Feb 25, 2003 |
6910485 |
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10172731 |
Jun 17, 2002 |
7176030 |
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09983021 |
Oct 22, 2001 |
6810881 |
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60467129 |
May 2, 2003 |
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Current U.S.
Class: |
422/62; 62/66;
62/68; 422/119; 128/849; 128/897; 422/3; 62/342; 62/72; 422/41;
422/105; 422/40 |
Current CPC
Class: |
A61B
50/13 (20160201); A61B 46/10 (20160201); A61F
7/0085 (20130101); A61B 2017/0023 (20130101); G01N
31/226 (20130101); A61B 2090/0814 (20160201) |
Current International
Class: |
A61L
2/24 (20060101) |
References Cited
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Primary Examiner: Sakelaris; Sally A
Attorney, Agent or Firm: Edell, Shapiro & Finnan,
LLC
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is: a continuation-in-part of U.S. patent
application Ser. No. 10/172,731, entitled "Method and Apparatus for
Ensuring Sterility of Disposable Medical Items Used with Medical
Equipment" and filed Jun. 17, 2002; now U.S. Pat. No. 7,176,030 and
a continuation-in-part of U.S. patent application Ser. No.
10/836,236, entitled "Surgical Drape with Conductor and Method of
Detecting Fluid and Leaks in Thermal Treatment System Basins" and
filed May 3, 2004, now U.S. Pat. No. 7,347,210 which is a
continuation-in-part of U.S. patent application Ser. No.
10/372,674, entitled "Medical Solution Thermal Treatment System and
Method of Controlling System Operation in Accordance with Detection
of Solution and Leaks in Surgical Drape Containers" and filed Feb.
25, 2003, now U.S. Pat. No. 6,910,485, which is a
continuation-in-part of U.S. patent application Ser. No.
09/983,021, entitled "Medical Solution Thermal Treatment System and
Method of Controlling System Operation in Accordance with Detection
of Solution and Leaks in Surgical Drape Containers" and filed Oct.
22, 2001, now U.S. Pat. No. 6,810,881. In addition, aforementioned
U.S. patent application Ser. No. 10/836,236 claims priority from
U.S. Provisional Patent Application Ser. No. 60/467,129, entitled
"Surgical Drape with Conductor and Method of Detecting Fluid and
Leaks in Thermal Treatment System Basins" and filed May 2, 2003.
The disclosures of the aforementioned patents and patent
applications are incorporated herein by reference in their
entireties.
Claims
What is claimed is:
1. A system for detecting conditions within containers formed by
surgical drapes during surgical procedures and controlling thermal
treatment of said containers in response to said detected
conditions, said system comprising: a thermal treatment unit to
thermally treat a sterile medium and including a basin; a surgical
drape, covering and substantially conforming to said basin, to
serve as a drape container for said sterile medium; a sensing
device to detect drape container conditions including sterility of
said drape, wherein said sensing device includes a status device
and a plurality of conductors responsive to contact with said
sterile medium to indicate conditions of said drape container, and
wherein said status device includes a plurality of states with the
state of said status device indicating said sterility of said
drape; a controller to operate said thermal treatment unit to
control a temperature of said basin; and a detection unit to
determine occurrence of said drape container conditions from
signals from said sensing device to control said controller to
operate said thermal treatment unit in accordance with said
determined drape container conditions.
2. The system of claim 1, wherein at least two of said conductors
are disposed on a sterile drape surface within said drape
container.
3. The system of claim 2, wherein said status device is coupled to
at least one of said conductors.
4. The system of claim 1, wherein said status device includes a
fuse.
5. The system of claim 2, wherein said sensing device includes a
strip with said plurality of conductors disposed thereon and a
connector to couple said sensing device to said detection unit.
6. The system of claim 5, wherein said connector includes said
status device and at least a portion of said plurality of
conductors.
7. The system of claim 5, wherein said strip includes a temperature
sensor coupled to at least one of said conductors to measure
temperature of said sterile medium.
8. The system of claim 5, wherein said sensing device detects a
change in a sterile medium amount within said drape container and
further includes at least one of a weight sensor to measure a
change in weight of said basin indicating said change in said
sterile medium amount, an optical sensor to detect an implement
within said basin altering said sterile medium amount, a proximity
sensor to detect said implement within said basin altering said
sterile medium amount, a Hall effect sensor to detect said
implement within said basin altering said sterile medium amount and
an RFID reader to detect an RFID label disposed on said implement
to detect said implement within said basin altering said sterile
medium amount.
9. The system of claim 1, wherein said sensing device includes a
connector with a processor to provide signals to said detection
unit to indicate at least one of said state and said drape
container conditions.
10. The system of claim 6 further including: a receptacle to
receive said connector and couple said sensing device to said
detection unit.
11. The system of claim 10, wherein said receptacle includes at
least one contact to engage a corresponding conductor of said
connector.
12. The system of claim 11, wherein each contact includes a
plurality of arms separated to receive and engage a corresponding
conductor therebetween.
13. The system of claim 1, wherein a first state of said status
device enables an electrical path and indicates a sterile drape,
and a second state of said status device disables said electrical
path and indicates prior use of that drape, and said detection unit
includes: a status module to provide a status signal on said
electrical path and detect characteristics of said electrical path
to determine said state of said status device and ascertain said
sterility of said drape.
14. The system of claim 13, wherein said status module determines a
random time interval and provides said status signal and determines
said status device state in response to expiration of that time
interval.
15. The system of claim 13, wherein said detection unit further
includes: an element module to disable said electrical path by
controlling said status device to enter said second state to
indicate use of said drape in response to detection of
characteristics indicating an enabled electrical path.
16. The system of claim 15, wherein said detection unit further
includes: a verification module to provide said status signal on
said electrical path to said status device and verify placement of
the status device in said second state, wherein detection of said
status device in said second state indicates a sterile drape and
detection of said status device in said first state indicates a
used drape utilizing a conductive member with said status device in
said second state.
17. The system of claim 1 further including a plurality of
indicators to indicate drape container conditions, wherein said
indicators are actuable in response to control signals generated by
said detection unit in accordance with said determined occurrence
of said drape container conditions.
18. The system of claim 1, wherein said drape container conditions
further include at least one of a leak and the presence of said
sterile medium within said drape container and said detection unit
disables said thermal treatment unit in response to determining at
least one of the presence of a leak, the absence of said sterile
medium within said drape container and said status indicating a
non-sterile drape.
19. The system of claim 1, wherein said drape container conditions
further include at least one of a leak and the presence of said
sterile medium within said drape container and said detection unit
enables said thermal treatment unit in response to determining the
presence of said sterile medium and absence of a leak within said
drape container.
20. The system of claim 1, wherein said thermal treatment unit is
operative to do at least one of heat and cool said sterile medium
in said drape container.
21. The system of claim 1, wherein said drape includes a pre-formed
container portion to form said drape container within said
basin.
22. The system of claim 1 further including a processor to collect
information relating to a surgical procedure and to generate a
report including said collected information.
23. The system of claim 22 further including: at least one of a bar
code scanner and an RFID reader to provide information to said
processor.
24. The system of claim 22 further including a printer to print a
hardcopy of said report.
25. The system of claim 24, wherein said printer is enabled after
system power down for a predetermined time interval.
26. The system of claim 22 further including a communications
module to establish communications and transfer information with
another device, wherein said processor generates said report in
electronic form and said communications module transmits said
report to said other device.
27. The system of claim 1, wherein said drape is formed of an
electrically conductive material.
28. The system of claim 1, wherein said drape is formed of an
electrically non-conductive material.
29. The system of claim 2, wherein said detection unit includes at
least one circuit path coupled to said at least two conductors to
receive signals from said sensing device to determine said drape
container conditions, and wherein said detection unit provides
power signals to at least one conductor in an oscillating fashion
to prevent said sterile medium from attaining a charge.
30. The system of claim 2, wherein said drape includes a pouch to
house said at least two conductors.
31. The system of claim 30, wherein said pouch is attached to said
drape via intermittent seams.
32. The system of claim 8, wherein said strip includes at least one
of said optical sensor, said proximity sensor and said Hall effect
sensor each coupled to at least one of said conductors.
33. A device for detecting conditions within a basin of a thermal
treatment system during surgical procedures and facilitating
control of thermal treatment of said basin and sterile medium
contained therein in response to said detected conditions, said
device comprising: a surgical drape to cover and substantially
conform to said basin to serve as a drape container for said
sterile medium; and a sensing device to detect drape container
conditions including sterility of said drape, wherein said sensing
device includes a status device and a plurality of conductors
responsive to contact with said sterile medium to indicate
conditions of said drape container, and wherein said status device
includes a plurality of states with the state of said status device
indicating said sterility of said drape.
34. The device of claim 33, wherein at least two conductors are
disposed on a sterile drape surface within said drape
container.
35. The device of claim 34, wherein said status device is coupled
to at least one of said conductors.
36. The device of claim 33, wherein said status device includes a
fuse.
37. The device of claim 33, wherein said sensing device includes a
strip with said plurality of conductors disposed thereon and a
connector to couple said sensing device to said thermal treatment
system.
38. The device of claim 37, wherein said connector includes said
status device and at least a portion of said plurality of
conductors.
39. The device of claim 37, wherein said strip includes a
temperature sensor coupled to at least one of said conductors to
measure temperature of said sterile medium.
40. The device of claim 37, wherein said sensing device detects a
change in a sterile medium amount within said drape container and
said strip includes at least one of an optical sensor to detect an
implement within said basin altering said sterile medium amount, a
proximity sensor to detect said implement within said basin
altering said sterile medium amount, and a Hall effect sensor to
detect said implement within said basin altering said sterile
medium amount, each coupled to at least one of said conductors.
41. The device of claim 33, wherein said sensing device includes a
connector with a processor to provide signals to said thermal
treatment system to indicate at least one of said state and said
drape container conditions.
42. The device of claim 33, wherein said drape includes a
pre-formed container portion to form said drape container within
said basin.
43. The device of claim 33, wherein said sensing device detects
drape container conditions further including at least one of the
presence of said sterile medium in said drape container and a leak
within said drape container.
44. The device of claim 33, wherein said drape is formed of an
electrically conductive material.
45. The device of claim 33, wherein said drape is formed of an
electrically non-conductive material.
46. The device of claim 34, wherein said drape includes a pouch to
house said at least two conductors.
47. The device of claim 46, wherein said pouch is attached to said
drape via intermittent seams.
48. A system for detecting conditions within containers formed by
surgical drapes during surgical procedures and controlling thermal
treatment of said containers in response to said detected
conditions, said system comprising: a thermal treatment unit to
thermally treat a sterile medium and including a basin; a surgical
drape, covering and substantially conforming to said basin, to
serve as a drape container for said sterile medium; a sensing
device including a plurality of conductors with at least two of
said conductors disposed on a sterile drape surface within said
drape container and responsive to contact with said sterile medium
to indicate conditions of said drape container; a controller to
operate said thermal treatment unit to control a temperature of
said basin; and a detection unit to determine occurrence of said
drape container conditions from signals from said sensing device to
control said controller to operate said thermal treatment unit in
accordance with said determined drape container conditions, wherein
said detection unit includes at least one circuit path coupled to
said at least two conductors to receive signals from said sensing
device to determine said drape container conditions, and wherein
said detection unit provides power signals to at least one
conductor in an oscillating fashion to prevent said sterile medium
from attaining a charge.
49. A device for detecting conditions within a basin of a thermal
treatment system during surgical procedures and facilitating
control of thermal treatment of said basin and sterile medium
contained therein in response to said detected conditions, said
device comprising: a surgical drape to cover and substantially
conform to said basin to serve as a drape container for said
sterile medium; and a sensing device including a plurality of
conductors with at least two of said conductors disposed on a
sterile drape surface within said drape container and responsive to
contact with said sterile medium to indicate conditions of said
drape container, wherein said drape includes a pouch to house said
at least two conductors.
50. The device of claim 49, wherein said pouch is attached to said
drape via intermittent seams.
51. A method of detecting conditions during surgical procedures
within a container formed within a thermal treatment system basin
by a surgical drape to contain sterile medium and controlling
thermal treatment of said drape container in response to said
detected conditions, said method comprising: (a) receiving said
surgical drape over said thermal treatment system to cover and
substantially conform to said basin to serve as a drape container
for said sterile medium, wherein said drape includes a sensing
device to detect drape container conditions including sterility of
said drape, wherein said sensing device includes a status device
and a plurality of conductors responsive to contact with said
sterile medium to indicate conditions of said drape container, and
wherein said status device includes a plurality of states with the
state of said status device indicating said sterility of said
drape; (b) determining occurrence of said drape container
conditions from signals from said sensing device and controlling
said thermal treatment system to thermally treat said basin in
accordance with said determined drape container conditions.
52. The method of claim 51, wherein at least two conductors are
disposed on a sterile drape surface and step (b) further includes:
(b.1) determining occurrence of drape container conditions from
signals from said plurality of conductors.
53. The method of claim 52, wherein said status device is coupled
to at least one of said conductors, and step (b) further includes:
(b.2) determining occurrence of said drape container conditions
based on the state of said status device indicating sterility of
said drape.
54. The method of claim 51, wherein said status device includes a
fuse.
55. The method of claim 52, wherein said sensing device includes a
strip with said plurality of conductors disposed thereon and a
connector, and step (a) further includes: (a.1) coupling said drape
to said thermal treatment system via said connector.
56. The method of claim 55, wherein said connector includes said
status device and at least a portion of said plurality of
conductors.
57. The method of claim 55, wherein said strip includes a
temperature sensor coupled to at least one of said conductors, and
step (b.1) further includes: (b.1.1) measuring temperature of said
sterile medium.
58. The method of claim 51, wherein step (b) further includes:
(b.1) detecting a change in a sterile medium amount within said
drape container, wherein said sensing device includes at least one
of a weight sensor to measure a change in weight of said basin
indicating said change in said sterile medium amount, an optical
sensor to detect an implement within said basin altering said
sterile medium amount, a proximity sensor to detect said implement
within said basin altering said sterile medium amount, a Hall
effect sensor to detect said implement within said basin altering
said sterile medium amount and an RFID reader to detect an RFID
label disposed on said implement to detect said implement within
said basin altering said sterile medium amount.
59. The method of claim 51, wherein said sensing device includes a
connector with a processor, and step (b) further includes: (b.1)
providing signals from said processor to said thermal treatment
system to indicate at least one of said status and said drape
container conditions.
60. The method of claim 56, wherein said thermal treatment system
includes a receptacle and step (a.1) further includes: (a.1.1)
receiving said connector in said receptacle to couple said drape to
said thermal treatment system.
61. The method of claim 51, wherein a first state of said status
device enables an electrical path and indicates a sterile drape,
and a second state of said status device disables said electrical
path and indicates prior use of that drape, and step (b) further
includes: (b.1) providing a status signal on said electrical path
and detecting characteristics of said electrical path to determine
said state of said status device and ascertain said sterility of
said drape.
62. The method of claim 61, wherein step (b.1) further includes:
(b.1.1) determining a random time interval and providing said
status signal and determining said status device state in response
to expiration of that time interval.
63. The method of claim 61, wherein step (b) further includes:
(b.2) disabling said electrical path by controlling said status
device to enter said second state to indicate use of said drape in
response to detection of characteristics indicating an enabled
electrical path.
64. The method of claim 63, wherein step (b) further includes:
(b.3) providing said status signal on said electrical path to said
status device and verifying placement of the status device in said
second state, wherein detection of said status device in said
second state indicates a sterile drape and detection of said status
device in said first state indicates a used drape utilizing a
conductive member with said status device in said second state.
65. The method of claim 51, wherein step (b) further includes:
(b.1) actuating at least one of a visual and an audio indicator to
indicate said determined occurrence of said drape container
conditions.
66. The method of claim 51, wherein said drape container conditions
further include at least one of a leak and the presence of said
sterile medium within said drape container, and step (b) further
includes: (b.1) disabling said thermal treatment system in response
to determining at least one of the presence of a leak, absence of
said sterile medium within said drape container and said status
indicating a non-sterile drape.
67. The method of claim 51 further including: (c) collecting
information relating to a surgical procedure and generating a
report including said collected information.
68. The method of claim 67, wherein step (c) further includes:
(c.1) providing information for said report via at least one of a
bar code scanner and an RFID reader.
69. The method of claim 67 further including: (d) printing a
hardcopy of said report.
70. The method of claim 69, wherein step (d) further includes:
(d.1) enabling printing of said report after system power down for
a predetermined interval.
71. The method of claim 67 further including: (d) establishing
communications and transferring information with another
device.
72. The method of claim 71, wherein step (d) further includes:
(d.1) generating said report in electronic form and transmitting
said report to said other devise.
73. The method of claim 51, wherein said drape container conditions
further include at least one of a leak and the presence of said
sterile medium within said drape container, and step (b) further
includes: (b.1) enabling said thermal treatment system in response
to determining the presence of said sterile medium and absence of a
leak within said drape container.
74. The method of claim 52, wherein at least one circuit path is
coupled to said at least two conductors to receive signals from
said sensing device to determine said drape container conditions,
and step (b.1) further includes: (b.1.1) providing power signals to
at least one conductor in an oscillating fashion to prevent said
sterile medium from attaining a charge.
75. The method of claim 52, wherein said drape includes a pouch to
house said at least two conductors.
76. The method of claim 75, wherein said pouch is attached to said
drape via intermittent seams.
Description
BACKGROUND OF THE INVENTION
1. Technical Field
The present invention pertains to thermal treatment systems. In
particular, the present invention pertains to detection of the
presence of solution and/or leaks within a drape container of a
thermal treatment system basin. The thermal treatment system
thermally treats a sterile surgical liquid placed within the drape
container and may be of the types disclosed in U.S. Pat. No.
4,393,659 (Keyes et al.), U.S. Pat. No. 4,934,152 (Templeton), U.S.
Pat. No. 5,163,299 (Faries, Jr. et al.), U.S. Pat. No. 5,331,820
(Faries, Jr. et al.), U.S. Pat. No. 5,333,326 (Faries, Jr. et al.),
U.S. Pat. No. 5,400,616 (Faries, Jr. et al.), U.S. Pat. No.
5,402,644 (Faries, Jr. et al.), U.S. Pat. No. 5,429,801 (Faries Jr.
et al.), U.S. Pat. No. 5,457,962 (Faries, Jr. et al.), U.S. Pat.
No. 5,502,980 (Faries, Jr. et al.), U.S. Pat. No. 5,522,095
(Faries, Jr. et al.), U.S. Pat. No. 5,524,643 (Faries, Jr. et al.),
U.S. Pat. No. 5,551,240 (Faries, Jr. et al.), U.S. Pat. No.
5,615,423 (Faries, Jr. et al.), U.S. Pat. No. 5,653,938 (Faries,
Jr. et al.), U.S. Pat. No. 5,809,788 (Faries, Jr. et al.), U.S.
Pat. No. 5,816,252 (Faries, Jr. et al.), U.S. Pat. No. 5,857,467
(Faries, Jr. et al.), U.S. Pat. No. 5,862,672 (Faries, Jr. et al.),
U.S. Pat. No. 5,879,621 (Faries, Jr. et al.), U.S. Pat. No.
5,950,438 (Faries, Jr. et al.), U.S. Pat. No. 6,003,328 (Faries,
Jr. et al.), U.S. Pat. No. 6,035,855 (Faries, Jr. et al.), U.S.
Pat. No. 6,087,636 (Faries, Jr. et al.), U.S. Pat. No. 6,091,058
(Faries, Jr. et al.), U.S. Pat. No. 6,255,627 (Faries, Jr. et al.),
U.S. Pat. No. 6,371,121 (Faries, Jr. et al.), U.S. Pat. No.
6,860,271 (Faries, Jr. et al.), U.S. Pat. No. 6,918,395 (Faries,
Jr. et al.) and U.S. Patent Application Publication Nos.
2004/0200483 (Faries, Jr. et al.) and 2004/0208780 (Faries, Jr. et
al.). The disclosures in the above-mentioned patents and patent
application publications are incorporated herein by reference in
their entireties.
2. Discussion of the Related Art
The above-referenced Keyes et al. patent (U.S. Pat. No. 4,393,659)
discloses a surgical slush producing system having a cabinet with a
heat transfer basin at its top surface. A refrigeration mechanism
in the cabinet takes the form of a closed refrigeration loop
including: an evaporator in heat exchange relation to the outside
surface of the heat transfer basin; a compressor; a condenser; and
a refrigeration expansion control, all located within the cabinet.
A separate product basin is configured to be removably received in
the heat transfer basin. Spacers, in the form of short cylindrical
stubs or buttons, are arranged in three groups spaced about the
heat transfer basin and projecting into the heat transfer basin
interior to maintain a prescribed space between the two basins.
During use, that space contains a thermal transfer liquid, such as
alcohol or glycol, serving as a thermal transfer medium between the
two basins. A sterile drape, impervious to the thermal transfer
medium, is disposed between the product basin exterior and the
liquid thermal transfer medium to preserve the sterile nature of
the product basin. Surgically sterile liquid, such as sodium
chloride solution, is placed in the product basin and congeals on
the side of that basin when the refrigeration unit is activated. A
scraping tool is utilized to remove congealed sterile material from
the product basin side to thereby form a slush of desired
consistency within the product basin. Some users of the system
employ the scraping tool to chip the solid pieces from the basin
side.
As noted in the above-referenced Templeton patent (U.S. Pat. No.
4,934,152), the Keyes et al. system has a number of disadvantages.
In particular, the separate product basin must be removed and
re-sterilized after each use. Additionally, the glycol or other
thermal transfer medium is highly flammable or toxic and, in any
event, complicates the procedure. The Templeton patent (U.S. Pat.
No. 4,934,152) discloses a solution to these problems by
constructing an entirely new apparatus whereby the product basin is
eliminated in favor of a sterile drape impervious to the sterile
surgical liquid, the drape being made to conform to the basin and
directly receive the sterile liquid. Congealed liquid is scraped or
chipped from the sides of the conformed drape receptacle to form
the desired surgical slush.
The Faries, Jr. et al. patent (U.S. Pat. No. 5,163,299) notes that
scraping congealed liquid from the drape is undesirable in view of
the potential for damage to the drape, resulting in a compromise of
sterile conditions. As a solution to the problem, the Faries, Jr.
et al. patent (U.S. Pat. No. 5,163,299) proposes that the drape be
lifted or otherwise manipulated by hand to break up the congealed
liquid adhering to the drape. Although this hand manipulation is
somewhat effective, it is not optimal, and often is inconvenient
and constitutes an additional chore for operating room personnel.
Accordingly, several of the Faries, Jr. et al. patents (e.g., U.S.
Pat. Nos. 5,331,820; 5,400,616; 5,457,962; 5,502,980; 5,653,938;
5,809,788; 5,857,467; 5,950,438; 6,003,328; and 6,035,855) resolve
the problem of manual drape manipulation by disclosing various
techniques and/or dislodgment mechanisms to automatically remove
the congealed liquid adhering to the drape without endangering the
integrity of the drape.
The Templeton patent (U.S. Pat. No. 4,934,152) further discloses an
electrical heater disposed at the bottom of the basin to convert
the sterile slush to warmed liquid, or to heat additional sterile
liquid added to the basin. Templeton describes the need for such
warm sterile liquid as occurring after a surgical procedure is
completed to facilitate raising the body cavity of the surgery
patient back to its normal temperature by contact with the warmed
liquid. However, there are a number of instances during a surgical
procedure when it is desirable to have simultaneous access to both
warmed sterile liquid and sterile surgical slush. Accordingly,
several of the Faries, Jr. et al. patents (e.g., U.S. Pat. Nos.
5,333,326; 5,429,801; 5,522,095; 5,524,643; 5,615,423; 5,653,938;
5,816,252; 5,862,672; 5,857,467; 5,879,621; 6,091,058; and
6,255,627) disclose a manner in which to simultaneously provide
both surgical slush and warmed surgical liquid during a surgical
procedure by utilizing a machine having plural basins with each
basin either producing surgical slush or heating a sterile liquid.
This machine typically utilizes a single surgical drape that forms
a drape receptacle within each basin to collect sterile slush and
heated sterile liquid produced by the machine in the respective
basins.
In addition, several of the drapes and thermal treatment systems
disclosed in the above-mentioned patents include specialized
features to enhance various aspects of thermal treatment system
operation. For example, some of the specialized features may
include: bladder drapes (e.g., as disclosed in U.S. Pat. Nos.
5,809,788; 5,950,438; and 6,003,328); drapes having plates or disks
(e.g., as disclosed in U.S. Pat. Nos. 5,457,962 and 5,502,980);
reinforced drapes (e.g., as disclosed in U.S. Pat. No. 5,857,467);
drape indicators and corresponding thermal treatment system
detection devices to ensure sterility by enabling system operation
in response to detecting a sterile drape placed on the system
(e.g., as disclosed in U.S. Pat. Nos. 5,653,938 and 5,879,621);
drapes having indicia to direct placement of the drapes on thermal
treatment systems (e.g., as disclosed in U.S. Pat. No. 5,615,423);
surgical drapes constructed of materials having a coefficient of
friction in a particular range and/or drapes including attachment
mechanisms such that a drape may withstand being drawn under a
dislodgment mechanism (e.g., as disclosed in U.S. Pat. No.
6,035,855); a stand to elevate objects within a heated basin above
the basin floor (e.g., as disclosed in U.S. Pat. No. 6,087,636)
and/or a heater configured to cover a portion of the basin (e.g.,
as disclosed in U.S. Pat. Nos. 6,091,058 and 6,255,627) to prevent
the drape from overheating and puncturing when objects are placed
within the basin; and remote control of a thermal treatment system
(e.g., as disclosed in U.S. Pat. Nos. 6,371,121, 6,860,271 and
6,918,395).
However, when insignificant amounts of liquid are present within a
thermal treatment system basin, the system heating and cooling
mechanisms operate with minimal thermal resistance, thereby
enabling the mechanisms to become damaged. Further, the drapes
employed by the system may be damaged by being disposed proximate
the heating or cooling mechanism without having the liquid to
absorb the thermal energy. Since only sterile drapes are to be used
during surgical procedures, a leak in a surgical drape compromises
sterility and contaminates the entire surgical procedure, thereby
increasing the risk of injury to a patient.
The related art has attempted to overcome this problem by employing
sensing devices with surgical drapes. For example, U.S. Pat. No.
5,524,643 (Faries, Jr. et al.) discloses a surgical drape combined
with a sensor, preferably attached to the drape, to detect the
presence of liquid within a drape container conforming to a
heating/cooling thermal treatment system basin. An alternative
embodiment employs sensors at opposite surfaces of the drape to
measure conductance and, thereby, leakage through the drape. A
microprocessor of each embodiment receives a signal representing,
for example, an electrical conductance measurement and determines
the presence of liquid and/or a leak. If liquid is not present or a
leak is determined to exist, the microprocessor disables a
temperature controller for the basin to prevent damage to the drape
and heating and cooling mechanisms.
U.S. Pat. No. 5,816,252 (Faries, Jr. et al.) discloses a drape for
use with a system for thermally treating a sterile medium. The
drape includes liquid sensitive material that changes color upon
contact with liquid to indicate the presence of a leak. The liquid
sensitive material may be placed between the drape and a receiving
basin or affixed to the drape in the form of indicia symbolically
directing placement of the drape over the system. The system may
include a single basin and be of the type that either thermally
cools or heats the sterile medium, or the system may include a
plurality of basins with each basin either thermally cooling or
heating the sterile medium. The liquid sensitive material detects
leaks within the drape while assisting the operator in properly
aligning and placing the drape over the system.
The above-described systems can stand some improvement. In
particular, the Faries, Jr. et al. sensor drape (U.S. Pat. No.
5,524,643) employs a plug connector disposed through the drape to
facilitate connections between the drape sensor and the thermal
treatment system, thereby complicating the process of effectively
sealing the drape to prevent contamination of the sterile field.
Further, the drape is required to be placed on the system with the
plug aligned with a corresponding plug receptacle for system
operation, thereby restricting the manners in which the drape may
be positioned on the system to form the drape container. The
Faries, Jr. et al. system employing liquid sensitive material with
a drape (U.S. Pat. No. 5,816,252) indicates the presence of a leak
within the drape container. However, this system relies on
operating room personnel to respond to the leak indication and
perform appropriate actions with respect to system operation. Thus,
the system may continually operate in the presence of a drape
container leak until personnel notice and respond to the leak
indication, thereby increasing the risk of contamination of a
surgical procedure and damage to the system heating or cooling
mechanism when a drape leak occurs.
OBJECTS AND SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to detect the
presence of solution and/or a leak within a drape container
disposed in a thermal treatment system basin and control system
operation in accordance with detected drape container
conditions.
It is another object of the present invention to dispose a
conductor or other object through a sterile surgical drape while
maintaining the sterile field.
Yet another object of the present invention is to employ a surgical
drape including solution and/or leak sensors with a thermal
treatment system including circuitry that interfaces the drape to
control system operation in accordance with drape conditions
detected by the sensors and circuitry.
still another object of the present invention is to limit
utilization of a sterile surgical drape to a single use to maintain
sterility of drapes for medical procedures.
A further object of the present invention is to detect tampering
with a sterile surgical drape to prevent the drape from being used
plural times with a thermal treatment system, thereby ensuring use
of a sterile drape for medical procedures.
The aforesaid objects may be achieved individually and/or in
combination, and it is not intended that the present invention be
construed as requiring two or more of the objects to be combined
unless expressly required by the claims attached hereto.
According to the present invention, a drape including a sensing
device is disposed over a top surface of a thermal treatment system
having a basin recessed therein. A portion of the drape is pushed
down into, and conforms to, the basin to form a drape container or
receptacle within the basin for collecting a sterile medium. The
thermal treatment system may be of the type that either heats or
congeals the sterile medium to respectively produce a warm sterile
liquid or sterile slush within the basin. The sensing device
includes electrodes that are typically disposed through the drape
and sealed. The electrodes provide signals indicating the presence
of liquid and/or leaks or other conditions within the drape
container to the system to facilitate control of system operation.
In addition, the sensing device includes a fuse to limit the drape
to a single use. The system disables the fuse to indicate prior use
and detects tampering to bypass the fuse, thereby preventing use of
the drape for subsequent medical procedures.
The above and still further objects, features and advantages of the
present invention will become apparent upon consideration of the
following detailed description of specific embodiments thereof,
particularly when taken in conjunction with the accompanying
drawings wherein like reference numerals in the various figures are
utilized to designate like components.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a view in perspective of a surgical drape placed over an
exemplary thermal treatment system to detect fluid and leaks within
a thermal treatment system basin according to the present
invention.
FIG. 2 is a view in perspective of the surgical drape of the
present invention for detecting the presence of fluid and leaks
within a thermal treatment system basin.
FIG. 3 is a top view in plan of the sensing device of the drape of
FIG. 2.
FIG. 4 is a side view in elevation and section of the surgical
drape of FIG. 2.
FIG. 5 is a perspective view of a plug of the drape sensing device
of FIG. 2 for engaging the thermal treatment system.
FIG. 6 is a view in elevation of the electrodes and plug of the
drape sensing device of FIG. 2.
FIG. 7 is a view in plan of a receptacle of the system of FIG. 1
for receiving the plug of the drape sensing device.
FIG. 8 is a view in elevation and partial section of contacts
within the receptacle of FIG. 7 to engage electrode traces of the
plug of the drape sensing device.
FIG. 9 is block diagram of control circuitry for the system of FIG.
1.
FIG. 10 is a schematic block diagram of an exemplary condition
circuit of the detection circuitry within the control circuitry of
FIG. 9 for determining the presence of liquid and/or leaks within a
drape container.
FIG. 11 is a detailed electrical schematic diagram of the exemplary
condition circuit of FIG. 10.
FIG. 12 is a procedural flow chart illustrating operation of the
thermal treatment system of FIG. 1.
FIG. 13 is an exploded perspective view of a surgical drape
including plural sensing devices and disposed over a plural basin
thermal treatment system according to the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
An exemplary thermal treatment system and drape to heat a sterile
medium (e.g., solution or liquid) and detect drape container
conditions according to the present invention is illustrated in
FIG. 1. Specifically, the system includes a cabinet or housing 31,
a wiring housing 45 attached to the cabinet and a warming basin 33
recessed into a cabinet top surface 34. The cabinet or housing may
be disposed on a stand 30, preferably including casters or rollers
for transport, or be utilized on a table or counter top. Basin 33
may be of any shape; however, by way of example only, the basin is
illustrated as being substantially rectangular. A power switch 37
and a temperature controller/indicator 38 are provided on top
surface 34 adjacent basin 33 and toward wiring housing 45. The
wiring housing is attached to the cabinet side wall that is closest
to power switch 37 and facilitates connections as described below.
A receptacle 49 is disposed on top surface 34 between the power
switch and temperature controller to couple a drape to the system
as described below. A heater 70 (FIG. 9) is disposed on the
underside and/or sides of the basin to heat the basin and the
sterile medium contained therein. The heater is controlled by
controller 38 in accordance with an entered desired temperature and
temperatures measured by a temperature sensor 72 (FIG. 9) as
described below. Heater 70 is typically implemented by a
conventional etched foil silicon rubber heating pad and is attached
to the basin via a pressure sensitive or other type of adhesive.
The heater may alternatively be of any quantity (e.g., at least
one), shape or size, and may include any configuration (e.g.,
strips, bars, segments, etc.) that covers the entirety or any
portion of the basin. In addition, the heater may be implemented by
any conventional or other type of heater or heating element (e.g.,
heating coils, etc.) that may be disposed on the basin at any
suitable locations.
Temperature sensor 72 is preferably implemented by a conventional
resistive temperature device (RTD) (e.g., a 1,000 Ohm RTD).
However, the sensor may be implemented by any conventional or other
type of temperature sensor, and may be disposed at any suitable
location on the basin or within the cabinet. It is to be understood
that the thermal treatment system described above may have various
configurations. For example, the thermal treatment system may be
configured to cool and/or congeal the medium to produce cooled
liquid or surgical slush. In this instance, the heater may be
replaced by refrigeration devices that are controlled in
substantially the same manner described below in response to
detection of solution and leaks within the drape container.
Further, the thermal treatment system may include a plurality of
basins warming and/or cooling a sterile medium. Examples of
warming, cooling and/or plural basin systems are disclosed in
several of the above-mentioned Faries, Jr. et al. patents (e.g.,
U.S. Pat. Nos. 5,333,326; 5,429,801; 5,522,095; 5,524,643;
5,615,423; 5,653,938; 5,816,252; 5,862,672; 5,857,467; 5,879,621;
6,091,058; and 6,255,627).
A sterile drape 17, preferably transparent, is typically disposed
over the top and sides of cabinet 31 and made to conform to the
side wall and bottom of basin 33. Power switch 37 and controller 38
are disposed on top surface 34 of system cabinet 31 and are
adjustable manually through drape 17. The portion of drape 17
disposed in basin 33 serves as a sterile container or receptacle
for sterile liquid placed therein to be heated. Typical sterile
liquid treated by the thermal treatment system is a 0.80% to 0.95%
sodium chloride solution (i.e., saline). Drape 17 is made from
materials that are impervious to the sterile liquid and
sufficiently soft and flexible to conform to a basin wall. The
thickness of the drape is preferably minimized to render thermal
transfer therethrough most efficient, yet the thickness is
sufficient to resist tearing and puncturing during normal use. The
drape may be made of materials commonly used in hospitals for
surgical drapes, or may be made of polyurethane film as disclosed
for the drape in U.S. Pat. No. 4,934,152 (Templeton). The drape
typically includes a conductivity above 100,000 Ohms in order to
enable a sensing device to detect drape conditions as described
below. Alternatively, the drape may be non-conductive and use
sensors to detect drape conditions as described below.
The drape may further include a preformed container portion
contoured to match the contour of a basin. The preformed container
portion may be (but is not necessarily) thicker than the remaining
portions of the drape described above in order to resist puncture
and enable the container portion to maintain the shape of the
basin. By way of example only, the container portion may be made of
a heavy gauge polyethylene/ionomer resin blend. The percentage of
ionomer resin in the blend is typically (but not necessarily) in
the approximate range of forty to seventy percent. The drape is
designed to be disposable after a single use to enhance patient
safety and is provided presterilized and prepackaged in a manner to
preserve its sterile state during storage.
The drape is typically positioned over the thermal treatment system
with a portion of the drape disposed in a basin to form a drape
receptacle as described above. The drape forms a sterile field
above the basin to maintain sterility of the sterile medium.
However, a puncture, tear or other opening in the drape disrupts
the sterile field and may contaminate the sterile liquid, thereby
risking injury to a patient. Further, the thermal treatment system
may damage the drape (e.g., via the heating or refrigeration
device) in the event that liquid is not present within the drape
container.
In order to detect the presence of liquid and/or leaks within the
drape container to maintain drape integrity and sterility of the
sterile medium, drape 17 includes a sensing device as illustrated
in FIGS. 2-3. Specifically, drape 17 is substantially rectangular
and includes a sensing device 90 to detect the presence of liquid
and leaks within a drape container. Sensing device 90 includes a
pair of electrodes 92, 94 that are affixed to a generally
rectangular strip 95 disposed on an intermediate portion of the
drape sterile surface. The electrodes are disposed on the electrode
strip and extend substantially in parallel. Electrode strip 95 may
further include electrodes 292, 294 with a sensor 272 disposed
therebetween (FIG. 6) to measure various conditions (e.g.,
temperature, withdrawal of liquid from the basin, etc.) within the
basin as described below. The electrodes of strip 95 are preferably
implemented by traces of silver or other metallic ink, but may be
implemented by any suitable conductors (e.g., wires, strips, etc.).
The electrode strip is enclosed, in whole or in part, within a
pouch 96 to secure the electrodes to the drape and to protect the
electrodes from sharp objects that may be disposed within the
basin. In addition, the pouch assists to prevent grounding of
electrodes 92, 94 or formation of a current flow path therebetween
due to placement of conductive objects (e.g., instruments,
stainless steel pitchers, etc.) in the basin that may produce
erroneous detections. The pouch is preferably formed from a
substantially rectangular segment or flap 98 that is attached via
any conventional or other techniques (e.g., heat welding, RF, heat
sealing, press or UV curing, pressure, etc.) to the drape sterile
surface and sealed by seams 93, each formed toward and extending
along a respective flap longer dimensioned edge. The seams may be
continuous (FIG. 2) or intermittent (FIG. 3) to allow greater
circulation of liquid over, around and/or through pouch 96 to
better facilitate the heating and/or cooling of liquid. The pouch
may be of one uniform surface or wedges that may include holes,
slits, lattices, cross-hatches or other manners of access for the
liquid to allow greater circulation.
The distal ends of the electrodes are attached to a plug or
connector 91 that interfaces detection circuitry within the thermal
treatment system as described below. The plug includes electrode
traces disposed on a plug rear surface. The distal portions of
strip 95 (and the electrodes) pass through the drape from the
sterile to the non-sterile drape sides via an opening or slit 97
defined in the drape at an intermediate location. Substantially
circular segments or patches 99, 101 are attached to the
non-sterile drape surface and to each other to seal opening 97 and
strip 95. The patches are each basically in a folded configuration
to encompass and seal the opening and strip in order to prevent
escape of liquid from, and maintain sterility of, the drape
container as described below.
Referring to FIG. 4, patches 99, 101 are each attached to the drape
non-sterile surface on respective opposing sides of opening 97.
Patch 99 includes a drape engagement section 102, a fold or bend
104 disposed at an intermediate patch location and a transverse
section 106 extending transversely relative to drape 17 from fold
104. Drape engagement section 102 of patch 99 is attached to the
non-sterile drape surface coincident pouch 96 with fold 104
disposed proximate opening 97. Patch 99 may be attached to the
drape via any conventional or other techniques (e.g., heat welding,
RF, heat sealing, press or UV curing, adhesives, pressure, etc.).
Transverse section 106 extends in a transverse direction relative
to the drape from fold 104 and along the bottom surface of strip 95
extending through opening 97.
Patch 101 is substantially similar to patch 99 and includes a drape
engagement section 103, a fold or bend 105 disposed at an
intermediate patch location and a transverse section 107 extending
transversely relative to drape 17 from fold 105. Drape engagement
section 103 of patch 101 is attached to the drape non-sterile
surface on the side of opening 97 opposing patch 99. Patch 101 may
be attached to the drape via any conventional or other techniques
(e.g., heat welding, RF, heat sealing, press or UV curing,
adhesives, pressure, etc.). Fold 105 is disposed proximate opening
97 with transverse section 107 extending in a direction transverse
to the drape from the fold along the top surface of strip 95. The
electrode strip is basically disposed between the transverse
sections of patches 99, 101, where the transverse patch sections
are fused or attached to each other and/or the drape non-sterile
surface via any conventional or other techniques (e.g., heat
welding, RF, heat sealing, press or UV curing, adhesives, pressure,
etc.) to effectively seal opening 97 and a portion of strip 95. The
strip extends beyond the sealed patches for connection to the
detection circuitry as described below. Flap 98 and patches 99, 101
are preferably constructed of drape materials; however, the flap
and patches may be constructed of any suitable materials, may be of
any shape or size, and may be disposed on the drape at any suitable
locations via any conventional or other techniques.
Referring back to FIGS. 1-3, sensing device 90 detects the presence
of liquid and leaks within the drape container in response to
placement of drape 17 over the thermal treatment system. In
particular, current flow between electrodes 92, 94 is initiated in
response to these electrodes contacting liquid. The liquid (or
current flow) causes a respective change in resistance (or voltage)
along a circuit path within detection circuitry of the thermal
treatment system that includes electrodes 92, 94. The changes
indicate drape container conditions and are detected by the
detection circuitry as described below. In order to enable the
liquid in the drape container to contact electrodes 92, 94 and
facilitate the above changes in the circuit path characteristics,
flap 98 includes a series of slots or other openings (e.g., holes,
slits, cross-hatches, lattices, etc.) 83. The slots or openings are
defined in the flap between seams 93 and are spaced from each other
in a direction of the flap longer dimension. If the slots are
utilized, they are generally rectangular and extend substantially
perpendicular to electrodes 92, 94. Each slot includes a longer
dimension substantially similar to the width of strip 95 and
encompasses portions of each electrode 92, 94 to facilitate
enhanced exposure of the electrodes to liquid within the drape
container. Alternatively, flap 98 may include a series of openings
(not shown) defined therein to permit contact between the liquid
and electrodes. Flap 98 may include any quantity of slots and/or
openings of any shape or size and disposed at any locations in any
desired fashion to facilitate contact between the electrodes and
liquid within the drape container.
Current flow between electrodes 92, 94 is initiated in response to
those electrodes contacting liquid, where the liquid (or current
flow) causes a respective change in resistance (or voltage) along
the circuit path within the detection circuitry as described above
that indicates the presence of solution within the drape container.
Further, the presence of a leak within the drape container enables
current to flow between electrodes 92, 94 and ground (e.g., the
basin beneath the drape), thereby providing a further change in
resistance (or voltage) along that circuit path. The detection
circuitry within the thermal treatment system detects the changes
to determine drape container conditions. In particular, the
detection circuitry initially applies a reference voltage or
potential to electrodes 92 and/or 94. This potential may be
provided in an intermittent fashion to prevent solution within the
basin from attaining a charge which may affect the current flow
between electrodes 92, 94 and cause erroneous detections. Since
electrodes 92, 94 are electrically isolated from each other within
strip 95 as described above, current flow between the electrodes is
prevented and the potential of and between those electrodes
basically remains unchanged.
When the sterile medium is placed in the drape container, the
sterile medium contacts electrodes 92, 94, thereby forming an
electrical path or conductive bridge between those electrodes.
Accordingly, current flow between electrodes 92, 94 is initiated in
response to those electrodes contacting liquid, thereby causing a
change in the resistance (or voltage) along a circuit path within
the detection circuitry including electrodes 92, 94 as described
above. Further, the presence of a leak within the drape container
enables current to flow between electrodes 92, 94 and ground (e.g.,
the basin beneath the drape), thereby causing a further change in
the resistance (or voltage) along that circuit path. The changes to
the circuit path characteristics resulting from each of the above
conditions is detected by the detection circuitry within the
thermal treatment system. This is typically accomplished by
detecting the voltage (or resistance) along the circuit path
including electrodes 92, 94. The resistance (or voltage) change in
the circuit path due to the presence of liquid or a leak is
utilized by the detection circuitry to detect the presence of
solution and/or leaks within the drape container and to control
system operation in accordance with the detected conditions as
described below. For example, the detection circuitry may disable
the thermal treatment system in response to the absence of liquid
or the presence of a leak within the drape container. In addition,
the detection circuitry may receive signals from electrodes 292,
294 to determine the conditions sensed by sensor 272 (e.g.,
temperature, withdrawal of solution, etc.).
Wiring housing 45 (FIG. 1) receives signals from the electrode
strip via receptacle 49, and includes wiring to transfer signals
between that housing and detection circuitry 100 (FIG. 9) to
facilitate detection of liquid and/or leaks and other conditions
within the drape container. Wiring housing 45 is in the form of a
generally rectangular box and is mounted on a cabinet side wall.
The wiring housing includes indicators, preferably in the form of
light emitting diodes 147, 149 and 151 to indicate drape container
conditions. By way of example only, the wiring housing includes:
green diode 147 to indicate operation of the system (e.g., solution
present without a drape container leak); yellow diode 149 to
indicate the absence of solution and leaks within the drape
container; and red diode 151 to indicate the presence of a leak
within the drape container. The wiring housing may alternatively be
disposed at any location on cabinet 31 (e.g., top surface, side
walls, cabinet interior, etc.), while the receptacle may be
disposed at any location on the cabinet or wiring housing.
Plug or connector 91 is illustrated is FIGS. 5-6. Specifically,
plug 91 includes a rear panel 20 with a substantially `U`-shaped
projection 25 attached to the lower portion of the front surface of
the rear panel. The plug includes an open front portion with the
projection defined by side walls 22, 24 and a bottom wall 26.
Electrodes 92, 94 extend from strip 95 and are disposed on the back
surface of rear panel 20. Further, an electrode 87 is disposed on
the panel back surface and coupled to electrode 92 via a fuse 89.
Electrode 87 provides signals to enable determination of the status
of the fuse (e.g., enabled or disabled) by the thermal treatment
system. The fuse status is utilized to indicate prior use of the
drape to the thermal treatment system to control system operation
as described below.
In addition, electrode strip 95 may further include electrodes 292,
294 with sensor 272 disposed therebetween (FIG. 6) to measure
various conditions (e.g., temperature, withdrawal of liquid from
the basin, etc.) within the basin. Electrodes 292, 294 extend from
strip 95 and are preferably covered with a non-conductive coating
and disposed on the back surface of rear panel 20 to provide
signals from sensor 272 for processing. The electrode strip may
include any quantity of electrodes and sensor arrangements to
measure various conditions. For example, the electrode strip may
include a sensor 272 in the form of a temperature or humidity
sensor (e.g., surface mounted diode, integrated circuit (IC) or
semiconductor temperature sensor, temperature diode, etc.), where
electrodes 292, 294 provide signals indicating solution temperature
or other conditions to control circuitry within cabinet 31 for
control and/or documentation purposes.
Alternatively, the electrode strip may include a sensor 272 in the
form of a proximity sensor to detect pitchers or other instruments
in the basin, or a chemical sensor to determine placement of the
correct fluid in the basin. Electrodes 292, 294 provide appropriate
signals to control circuitry within cabinet 31 to process the
sensor signals.
Plug 91 may alternatively include a processor 65 to enable system
operation with the drape. The processor is preferably in the form
of a suitably sized integrated circuit or chip and may be
implemented by any conventional or other processor or processing
system (e.g., microprocessor, controller, circuitry, etc.) to
generate signals for the thermal treatment system. For example, the
processor may be coupled to electrodes 92, 94, 292, 294 to process
the electrode signals and determine drape container and fuse
conditions. The processor subsequently transmits appropriate
control signals to the thermal treatment system to control
operation (e.g., enable the heater and/or temperature controller in
response to the presence of solution, disable the heater and/or
temperature controller in response to a disabled fuse, the absence
of solution or the presence of a leak, control actuation of visual
and/or audio indicators, etc.). The processor may provide the
appropriate signals (e.g., associated with the electrodes and fuse)
to receptacle 49 to enable the detection circuitry to control the
thermal treatment system in the manner described below. The
processor may alternatively provide signals to receptacle 49 that
are transmitted to the appropriate components (e.g., heater,
temperature controller, visual or audio indicators, etc.) to
control system operation. In addition, the processor may be
utilized in place of the fuse and store information relating to use
of the drape. If the drape has prior use, the processor provides a
signal indicating this status to the thermal treatment system to
disable system operation.
Receptacle 49 receives plug 91 to provide electrode signals to the
thermal treatment system. Referring to FIGS. 1, 7-8, receptacle 49
includes a rectangular housing with an open top portion to receive
plug 91. The open top portion is partitioned into a series of
contact receptacles 15 providing contacts for the electrodes
disposed on the plug. By way of example, the receptacle includes
five contact receptacles 15 with three contact receptacles
receiving the electrode signals (e.g., electrodes 87, 92 and 94)
from the plug. However, any quantity of contact receptacles may be
employed (e.g., for electrodes 292, 294) to process signals from
any quantity of sensor arrangements. The contact receptacles are
configured for high current to extend the life of receptacles 15
and enable repeated usage of drapes with the thermal treatment
system. Each contact receptacle 15 includes a contact 86 (FIG. 8)
to receive a corresponding electrode. Contact 86 is in the form of
a clamp with arms 14, 16 separated by a slight distance to receive
an electrode therebetween. The configuration of plug 91 enables
insertion of the plug into contacts 86 of receptacles 15, where
electrodes from the plug (e.g., electrodes 87, 92, 94, 292, 294)
reside between arms 14, 16 of corresponding contacts 86. The
`U`-shaped projection of plug 91 serves as a stop against the
distal ends of arms 16 of contacts 86. Each contact is spring
biased to enable the contact arms to engage a corresponding
electrode and transfer signals between that electrode and the
thermal treatment system.
The system detection circuitry receives signals from the
electrodes, via plug 91 and receptacle 49, and basically prevents
system operation (e.g., disables controller 38) in response to a
leak or the absence of liquid within the drape container, in
response to the absence of a connection between the drape and the
thermal treatment system, or in response to a disabled fuse
indicating drape prior use. In other words, the detection circuitry
determines the drape container or other conditions (e.g., from
sensor 272) based on the electrode signals and controls system
operation accordingly. In addition, the detection circuitry may
selectively illuminate the diodes to indicate the particular
determined drape container conditions (e.g., no fluid, the presence
of a leak, etc.). The wiring housing receives signals from
connector 91 via receptacle 49. The wiring housing further
facilitates connections via appropriate wiring between the
receptacle, diodes and a circuit board 52 (FIG. 9) of the detection
circuitry containing a condition circuit 53 (FIG. 10) as described
below. Fuses may be employed to protect the system circuitry from
power surges and/or spikes that may cause damage to the system.
Referring to FIGS. 1 and 9, cabinet 31 houses control circuitry
including power switch 37, temperature controller 38, receptacle
49, a power supply 54 and detection circuitry 100. Power supply 54
provides appropriate power signals to the control circuitry
components and includes a receptacle to receive signals from a
power cord 61 (FIG. 1) interfacing a conventional wall outlet jack.
The power switch enables power to the circuitry components and may
be implemented by any conventional or other switching device. Plug
or connector 91 is received in receptacle 49 to transfer signals
between the electrodes and the detection circuitry. This further
enables the detection circuitry to detect the presence of a drape
on the system as described above. The temperature controller
controls the heater, while the detection circuitry determines the
drape container conditions based on the electrode signals and
controls the temperature controller accordingly. The wiring housing
may include audio and/or visual indicators (e.g., beeper or buzzer,
speaker 197 (FIG. 10), various colored light emitting diodes (e.g.,
green diode 147, yellow diode 149 and red diode 151), etc.) to
indicate drape container conditions as described above. The
detection circuitry may selectively actuate the indicators in any
fashion to indicate the particular determined drape container
conditions (e.g., absence of the drape or solution, the presence of
a leak, etc.). The control circuitry components may be disposed on
and/or within the cabinet and/or wiring housing in any fashion at
any desired locations.
Temperature controller 38 is connected to heater 70 and temperature
sensor 72 to control the heater in response to a desired or set
point temperature entered by a user and the temperature measured by
the temperature sensor. In particular, temperature controller 38 is
typically implemented by a conventional temperature controller or
microprocessor and includes a display 47 and input devices 43
(e.g., buttons, keys, etc.). The temperature controller controls
power to the heater based on a comparison of the temperature
measured by temperature sensor 72 and the set point temperature
entered by the user via input devices 43. The temperature
controller may further display the measured and/or set point
temperatures or any other desired information on display 47. The
information to display may be selected by a user via input devices
43. When the measured temperature exceeds the set point
temperature, controller 38 disables or reduces power to the heater.
Conversely, when the measured temperature is below the set point
temperature, controller 38 enables or increases power to the
heater. Alternatively, the temperature controller may control the
heater in accordance with solution temperature measured by sensor
272 of electrode strip 95.
A thermostat 68 may be disposed between the controller and heater
to disable current to heater 70 in response to a temperature
measurement exceeding a temperature threshold. The thermostat
disables the heater in response to detection of excessive heater
temperatures and may be implemented by any conventional switching
type or limiting devices, such as a high limit thermostat, and
disposed at any suitable location.
Temperature controller 38 further controls heater 70 in response to
signals received from detection circuitry 100. The detection
circuitry detects the presence of solution and leaks within the
drape container and provides appropriate signals to temperature
controller 38. The detection circuitry basically disables the
temperature controller (and heater) in response to absence of the
drape, absence of solution within the drape container, a previously
used or non-sterile drape, and/or the presence of a drape container
leak as indicated by the electrode signals. The detection circuitry
preferably includes a microprocessor to process electrode signals
and control the indicators, heater or any other devices as
described below.
Exemplary detection circuitry for the system includes circuit board
52 including condition circuit 53 (FIG. 10) and green, yellow and
red diodes 147, 149, 151 indicating the drape container conditions.
The circuit board further includes a series of pins or terminals
1-12 to facilitate connections and a plurality of indicator lights
79. By way of example only, pins 1 and 2 are connected to
receptacle or connector 49 to receive signals from electrodes 92,
94, while pins 9 and 11 are connected to the positive and reference
terminals of power supply 54, respectively. Pins 6-8 are connected
to pin 9 and provide a voltage (e.g., +5V DC) to the condition
circuit, while pin 12 is connected to pin 11 and provides a ground.
Green diode 147 is connected between pins 3 and 6 and is
illuminated in response to detection of solution within the drape
container without a leak, while yellow diode 149 is connected
between pins 4 and 7 and is illuminated in response to detection of
the absence of solution and a leak within the drape container. Red
diode 151 is connected between pins 5 and 8 and is illuminated in
response to detection of a leak within the drape container. Pin 10
is basically inoperable and utilized to facilitate compatible
connections with the board. The circuit board may include any
quantity of pins to accommodate any desired inputs (e.g.,
electrodes 292, 294, etc.).
An exemplary condition circuit 53 for detecting the presence of
solution and leaks within the drape container is illustrated in
FIGS. 10-11. Initially, the condition circuit prevents operation of
the thermal treatment system in the event a drape is damaged (e.g.,
contains a leak) or not connected to the detection circuitry, in
the event the fuse of plug 91 is disabled indicating prior use of
the drape, or in the event solution is absent from the drape
container. The condition circuit is coupled to drape electrodes 92,
94 via respective pins 1 and 2 of circuit board 52. The presence of
solution within the drape container causes current flow between
electrodes 92, 94 and along a circuit path within the condition
circuit including those electrodes, while a leak facilitates
current flow between electrodes 92, 94 and ground (e.g., the basin)
as described above. Accordingly, the current flow causes a change
in resistance (or voltage) in the circuit path, including pins 1
and 2 of the circuit board, thereby enabling detection of solution
and leaks by the condition circuit. In particular, the condition
circuit includes a microprocessor 190 (e.g., receiving supply
voltage (e.g., 5V DC) and a ground with a capacitor 114 disposed
therebetween) and a power switch 196. The microprocessor includes
comparator logic 184 to compare signals provided to the
microprocessor as described below. Pin 1 of circuit board 52
effectively provides electrode signals to an inverting input of
comparator logic 184 and is coupled to fuse 89 of plug 91 via
electrode 92. The inverting input is further connected to a
resistor 191 (e.g., 100K Ohms) disposed in series with a supply
voltage (e.g., 5V DC) and to a resistor 198 (e.g., 3.9 Ohms)
connected in series with a switch 194 and the supply voltage (e.g.,
5V DC). A resistor 186 (e.g., 180 Ohms) is connected between the
inverting input and an output of microprocessor 190. The switch
enables the system to disable fuse 89 to indicate prior use and is
preferably implemented by a transistor 199 (e.g., FET, etc.) with a
source coupled to the supply voltage and a drain coupled to
resistor 198. The gate of the transistor is coupled to an output of
microprocessor 190 and to a resistor 192 (e.g., 2.7K Ohm) disposed
between the gate and the supply voltage. The switch and
corresponding circuitry enable the microprocessor to disable fuse
89, while resistor 186 and the microprocessor enable detection of
the fuse as described below.
The inverting input of comparator logic 184 is coupled to
additional circuitry (FIG. 11) (e.g., a resistor 117 (e.g., 2.7K
Ohm) connected in series with pin 1, a resistor 136 (e.g., 270 Ohm)
disposed between the inverting input and microprocessor 190, a
capacitor 111 (e.g., 0.1 .mu.f) connected between the inverting
input and a ground potential, a diode 195 connected between the
inverting input and the supply voltage, and diodes 109, 115
connected in parallel between pins 1 and 2) to enable proper
operation, protect the circuit from damage in the event an external
voltage is applied to pins 1 and 2 and/or to provide filtering to
prevent a response to noise. The non-inverting input of comparator
logic 184 is coupled to a reference voltage (e.g., 2.5V DC). This
potential may be produced by a voltage divider circuit including
resistors 126, 128 (e.g., each 2.7K Ohms) arranged in series and
coupled to the supply voltage (e.g., 5V DC).
Pin 2 is connected to an output of microprocessor 190 with a
resistor 193 (e.g., 2.7K Ohm) disposed between the pin and the
microprocessor output. The microprocessor output provides either a
ground potential or a high impedance state to detect solution or
leaks within the drape container as described below. Pin 2 is
further coupled to a diode 118 disposed between the pin and a
ground potential. These items enable proper operation, protect the
circuit from damage in the event an external voltage is applied to
pins 1 and 2 and/or to provide filtering to prevent a response to
noise.
Comparator logic 184 determines the presence of drape container
conditions by comparing the potential of pin 1 (coupled to the
inverting input) to the reference voltage (e.g., 2.5V DC). In order
to detect the presence or absence of solution within the drape
container, the microprocessor provides a ground potential at the
microprocessor output coupled to pin 2. The configuration of the
condition circuit basically forms a voltage divider circuit from
the supply voltage (e.g., 5V DC) through resistor 191 (e.g., 100K
Ohms), solution between pins 1 and 2 and resistor 193 (e.g., 2.7K
Ohms) to the ground potential. The potential of pin 1 is based on
the combined resistance of the solution and resistor 193. If the
resistance between pins 1 and 2 (e.g., of the solution) is below
97.3K Ohms indicating the presence of solution in the basin, the
voltage divider circuit produces a voltage on pin 1 less than the
reference voltage (2.5V DC) since the combined resistance of the
solution and resistor 193 (e.g., 2.7K Ohms) is less than the
resistance of resistor 191 (e.g., 100K Ohms). Accordingly,
comparator logic 184 produces a high level signal to indicate the
presence of solution. The microprocessor subsequently provides a
signal to illuminate green diode 147 and actuate power switch
circuitry 196 to enable heater 70 and temperature controller 38 in
response to the signal indicating the presence of solution without
a leak in the drape container.
Power switch circuitry 196 includes an optocoupler 150 and a triac
154. The triac is connected between conductors 160, 162 that
provide signals to temperature controller 38, and has a gate
terminal coupled to an output of the optocoupler. Another
optocoupler output is coupled to circuit board pin 3 and, hence, to
green diode 147 disposed between circuit board pins 3 and 6, while
a resistor 158 (e.g., 180 Ohm) is connected between pin 3 and the
optocoupler. An output of the microprocessor is connected to an
input of the optocoupler to drive the power switch circuitry in
response to the presence of solution without a leak in the drape
container as described above. A resistor 152 (e.g., 22 Ohms) is
connected to an optocoupler output and in series with the triac. A
low level logic signal produced by the microprocessor provides a
ground that enables the optocoupler input to receive appropriate
current to produce outputs that drive the triac. Thus, the low
level logic signal from the microprocessor enables actuation of the
green diode and triac to indicate the presence of solution without
a leak in the drape container and to enable the heater and
temperature controller, respectively. The triac basically enables
and provides signals to temperature controller 38 to control
actuation of the heater as described above.
When solution is absent from the basin, the voltage divider circuit
basically forms an open circuit between pins and 1 and 2.
Accordingly, pin 1 has the potential of the supply voltage (e.g.,
5V DC) that exceeds the reference voltage (e.g., 2.5 V DC), and
comparator logic 184 produces a low level signal to indicate the
absence of solution. The microprocessor provides a signal to
actuate yellow diode 149 in response to the comparator signal
indicating the absence of solution and a leak within the drape
container. The yellow diode is disposed between circuit board pins
4 and 7 with a resistor 170 (e.g., 270 Ohm) connected between pin 4
and the microprocessor output. A low level logic signal produced by
the microprocessor provides a sufficient voltage differential to
enable pin 7 connected to a supply voltage (e.g., 5V DC) to
illuminate yellow diode 149.
In order to detect leaks, the microprocessor provides a high
impedance state at the microprocessor output coupled to pin 2. This
effectively removes resistor 193 from the voltage divider circuit
path. When a leak is present in the drape, the solution creates the
voltage divider path from the supply voltage (e.g., 5V DC) through
resistor 191 (e.g., 100K Ohms), pin 1 and the solution to a ground
potential (e.g., the basin). In this case, the potential of pin 1
is based on the resistance of the solution. If the resistance
between pins 1 and 2 (e.g., of solution) is below 100K Ohms
indicating the presence of a leak, the voltage divider circuit
produces a voltage on pin 1 less than the reference voltage (2.5V
DC) since the resistance of the solution is less than the
resistance of resistor 191 (e.g., 100K Ohms). Accordingly,
comparator logic 184 produces a high level signal to indicate the
presence of a leak. Microprocessor 190 produces an oscillating
output or pulse train responsive to the output of the comparator
logic. The oscillating output of the microprocessor is coupled to a
reference terminal of a speaker 197 and to pin 5 for actuating red
diode 151. A resistor 143 (e.g., 270 Ohm) is disposed between pin 5
and the oscillating output, while a speaker positive terminal is
connected to a supply voltage (e.g., 5V DC). The oscillating output
is in the form of a pulse train that provides periodic low level
logic signals. The low level signals provide a sufficient voltage
differential to enable the supply voltages of the red diode (e.g.,
5V DC of pin 8) and speaker (e.g., 5V DC of the speaker positive
terminal) to drive those devices. Thus, the microprocessor produces
a pulse train that enables the diode to flash and the speaker to
beep at rates proportional to the pulse train frequency when a leak
is present in the drape container.
The microprocessor further indicates and detects prior use of a
drape by sensing and altering the state of fuse 89 as described
below. In particular, the microprocessor initially detects the
presence of fuse 89 of a drape prior to system operation. Once the
fuse is detected, the microprocessor provides a signal of
sufficient current to disable the fuse, thereby preventing
subsequent detection of an enabled fuse and re-use of that drape
with the system. The microprocessor further detects the presence of
the fuse after disablement prior to initiating system operation to
prevent a user from bypassing the fuse circuit with a conductive
element (e.g., coin, etc.).
Comparator logic 184 may be further utilized to detect the presence
of an enabled fuse 89. In particular, a voltage divider circuit is
basically formed and includes resistor 186 (e.g., 180 Ohms), pin 1
and fuse 89. The resistor and fuse serve as the resistive elements
for the voltage divider arrangement. Microprocessor 190 provides an
initial supply voltage (e.g., 5V DC) to flow from the
microprocessor through resistor 186, pin 1 and the fuse to a ground
potential. When a drape is provided with a disabled fuse (e.g., an
attempt to re-use the drape), the voltage divider effectively
includes an open circuit between the pin and ground, and pin 1 has
the potential of the supply voltage (e.g., 5V DC). Since pin 1
(e.g., 5V DC) exceeds the reference voltage (e.g., 2.5 V DC),
comparator logic 184 produces a low level signal to indicate the
disabled state of the fuse. The microprocessor prevents system
operation until a drape with an enabled fuse is provided for use
with the system.
If the resistance between pin 1 and ground (e.g., resistance of the
fuse) is below 180 Ohms indicating the presence of the fuse, the
voltage divider circuit produces a voltage on pin 1 less than the
reference voltage (2.5V DC) since the resistance of the fuse is
less than that of resistor 186 (e.g., 180 Ohms). Comparator logic
184 produces a high level signal to indicate the presence of the
fuse. The microprocessor subsequently disables the fuse as
described below and initiates system operation in response to
verifying the disabled state of the fuse. The current through the
fuse may be derived from the supply voltage and resistance (e.g.,
5V/180 Ohms=0.027 Amps).
In order to disable the fuse, microprocessor 190 is coupled to and
provides a signal to control switch 194. Basically, the
microprocessor provides a ground potential to provide a path for
the supply voltage (and current) to the gate of transistor 199.
This enables the transistor to conduct and places the switch in a
closed state. Current subsequently flows through the switch to pin
1, thereby disabling fuse 89. The current for disabling the fuse is
derived from the supply voltage divided by the resistance (e.g.,
5V/(3.9 Ohms of resistor 198+the external resistance)). The
microprocessor subsequently detects the disabled state of the fuse
in the manner described above prior to enabling system operation in
order to prevent users from bypassing the fuse circuit via a
conductive element (e.g., inserting a conductive element to emulate
the presence of the fuse).
The condition circuit basically controls system operation in
response to detected drape container conditions. The circuit is
arranged to enable signals from the microprocessor to selectively
facilitate a particular action (e.g., illuminate the red diode and
speaker, enable the green diode and heater, illuminate the yellow
diode, etc.) in response to the occurrence of corresponding
conditions for that action. In other words, a particular action is
initiated by the condition circuit in response to the occurrence of
corresponding conditions, while remaining actions are disabled.
Thus, the green diode and heater are enabled by the condition
circuit in response to the presence of solution without a leak in
the drape container, and are disabled during occurrence of other
drape container conditions (e.g., a leak or no solution within the
drape container). Enablement and disablement of the yellow diode
and red diode and speaker are facilitated in a similar manner with
respect to their corresponding conditions. The condition circuit
and/or circuit board may further include circuitry to record the
time and/or date when the system or heater is enabled and disabled
or any other information. The stored information may be retrieved
for hospital records or to assist in evaluating system
performance.
The manner in which the condition circuit operates is described
with reference to FIGS. 11-12. Initially, the system is enabled and
initialized at step 200. The microprocessor flashes red and yellow
diodes 149, 151 at step 202. This may be accomplished by the
microprocessor providing an output signal in the form of a pulse
train to flash those diodes. The microprocessor subsequently
determines a random delay interval, preferably in the range of 0.25
to 3.0 seconds, and waits for expiration of the interval at step
204 prior to detecting the presence of fuse 89. This random delay
prevents users from bypassing the safety feature of the drape
(e.g., using a new drape to initiate system operation, while
employing a different drape for the medical procedure, etc.) as
described below. The microprocessor provides a supply voltage
(e.g., 5V DC) to resistor 186 to detect the presence of an enabled
fuse as described above. If the fuse is present, the voltage
divider arrangement enables pin 1 to have a voltage less than that
of the reference voltage (e.g., since the resistance of fuse 89 is
less than that of resistor 186) as described above, and comparator
logic 184 produces a high level signal. When the fuse is disabled,
the voltage divider arrangement enables pin 1 to have the potential
of the supply voltage (e.g., 5V DC) as described above. In this
case, pin 1 exceeds the reference voltage and comparator logic 184
produces a low signal. If the fuse is disabled as determined at
step 206, the microprocessor repeatedly determines a new random
delay interval and detects the presence of an enabled fuse as
described above until an enabled fuse is sensed. The microprocessor
basically prevents system operation until a drape with an enabled
fuse is provided for system use. These conditions further prevent
use of the system without a drape or with drapes (e.g., plain
drapes, etc.) lacking the sensing device and/or fuse. The random
nature of the interval inhibits users from initially using a drape
with a fuse and subsequently substituting the initial drape with
previously used or non-compatible drapes since users would not know
the appropriate time to switch the drapes to bypass the
sensing.
When a fuse is detected as determined at step 206, the
microprocessor waits for a predetermined interval (e.g., 0.04
seconds) at step 208 prior to disabling the fuse. The
microprocessor provides a signal to fuse 89 of sufficient current
to render the fuse inoperable as described above. Once the signal
has been sent, the microprocessor detects the presence of a
disabled fuse in the manner described above to ensure that a user
is not attempting to bypass a disabled fuse with a conductive
element (e.g., using a coin or other conductor to provide a
conductive path and simulate the presence of an enabled fuse). If
the microprocessor receives a signal from comparator logic 184
indicating an enabled fuse after fuse disablement as determined at
step 210, this indicates use of a conductive element in place of
the fuse in an attempt to bypass the system. Accordingly, the
microprocessor produces a quick beep from speaker 197 and flashes
yellow and red diodes 149, 151 at step 214 to notify personnel of
this condition. This continues until system reset, where a new
drape may be provided for system use.
If the fuse is confirmed to be disabled as determined at step 210,
the microprocessor performs an initialization at step 212 (e.g.,
resets diodes, flags, timers, etc.) and waits for a predetermined
interval (e.g., one second) at step 216 prior to detecting drape
container conditions.
The microprocessor detects the presence of a leak at step 220.
Initially, microprocessor 190 places an output coupled to resistor
193 in a high impedance state as described above, where pin 1 has
the potential of the supply voltage. When a leak occurs, a
conductive path is formed from the supply voltage through resistor
191, pin 1 and the solution to a ground potential (e.g., the
basin). This forms a voltage divider circuit (e.g., from the supply
voltage through resistor 191 and pin 1 to ground), where the lesser
resistance of the solution relative to resistor 191 enables the
potential of pin 1 to be reduced below the comparator logic
reference potential (e.g., 2.5V DC) as described above, thereby
causing comparator logic 184 to produce a high level logic signal.
When a leak is present as determined at step 220, the
microprocessor detects the comparator signal and illuminates red
diode 151 and actuates speaker 197 to provide an audio leak
indication at step 222.
When a leak is absent, the microprocessor detects the presence of
solution in the basin at step 224. Initially, microprocessor 190
places an output coupled to resistor 193 at a ground potential. In
the event that solution is present in the drape container, a
conductive path is formed from the supply voltage through resistor
191, pin 1, the solution, pin 2 and resistor 193 to the ground
potential forming a voltage divider as described above. The voltage
divider provides pin 1 with a voltage less than the reference
voltage (e.g., 2.5V DC) since the combined resistance of the
solution and resistor 193 (e.g., 2.7K Ohms) is less than the
resistance of resistor 191 (e.g., 100K Ohms). Accordingly, the
output of comparator logic 184 is high to indicate the presence of
solution. When solution is absent from the drape container, no
current flow exists between the drape electrodes and the voltage
divider effectively includes an open circuit with pin 1 having the
potential of the supply voltage. In this case, since the voltage
applied to pin 1 (e.g., 5V DC) is greater than the reference
voltage (e.g., 2.5V DC), the output of comparator logic 184 is low
to indicate the absence of solution.
When solution is present as determined at step 224, the
microprocessor detects the high comparator logic signal and sets a
solution flag, illuminates green diode 147, actuates power switch
196 to enable the heater and temperature controller 38, and
increments a counter or timer at step 226. The timer maintains a
time interval for operation of the system (e.g., twelve hours,
etc.). If the time interval expires as determined at step 218, the
system resets to repeat the above process at step 202. Otherwise,
the microprocessor waits for expiration of the time interval at
step 216 and repeats the detection for leaks and solution.
If solution is absent from the drape container, the microprocessor
detects the low comparator logic signal and determines the state of
the solution flag at step 228. If the solution flag is set
indicating the basin had solution, the microprocessor provides an
audio beep indication to speaker 197 and flashes yellow diode 149
at step 232. This condition generally indicates placement of a new
drape on the system (e.g., an old drape with solution is removed
from the system and a new drape is placed on the system). The
microprocessor subsequently waits for the random interval at step
204 and repeats the above process.
When the solution flag is not set indicating the basin has yet to
receive solution, the microprocessor flashes yellow diode 149 at
step 230. The microprocessor subsequently waits for expiration of
the time interval at step 216 and repeats the detection for
solution and leaks.
The condition circuitry may employ any conventional or other
components with any desired electrical properties (e.g.,
resistance, capacitance, etc.) that can perform the above-described
functions. The potential provided to electrodes 92 and/or 94 for
detecting drape container conditions may be supplied in an
intermittent manner to prevent the solution within the drape
container from attaining a charge and affecting the potential
across those electrodes which may cause erroneous detections. This
may be accomplished by an oscillating power supply or via
microprocessor 190. The reference voltage utilized by comparator
logic 184 may be any suitable voltages. By way of example only, the
reference voltage utilized by the comparator logic and/or the
component electrical properties in the condition circuit may be
derived from the properties of the solutions employed. Further, the
reference voltage and/or electrical properties may be adjusted to
account for objects placed in the basin. For example, placement of
conductive objects (e.g., instruments, etc.) within the basin may
establish a path for current flow between the conductive segments
irrespective of the presence of solution, thereby enabling the
condition circuit to indicate erroneous conditions. Accordingly,
the reference voltage may be adjusted to differentiate between
current flow initiated by solution and the current flow initiated
by a conductive object. Alternatively, conductive objects may be
utilized in combination with a stand disposed within the basin to
elevate the objects above the conductive segments and basin floor
in a manner similar to that disclosed in U.S. Pat. No. 6,087,636
(Faries, Jr. et al.).
In addition, the control circuitry may include devices to measure,
record and/or provide a report (e.g., hardcopy or electronic form)
of system conditions (e.g., time, date, temperature, leak
indication, etc.). The report provides medical personnel
documentation for their files on the heating characteristics. The
primary information produced is the start date and start time of
solution heating, the time interval the solution was heated and the
temperature the solution attained during heating (e.g., partial or
complete history of time and solution temperature). The solution
temperature may be measured by sensor 272. For example, the report
may include a graphical plot of solution temperature (e.g., time
versus temperature) with indicators indicating the time of
withdrawal of solution from the basin. The report may further
include a variety of information (e.g., facility name and location,
patient information, doctor information, type of procedure, type of
solution and/or instruments being heated, amount of solution being
heated, time of withdrawal of solution from the basin, etc.).
Referring back to FIG. 9, the control circuitry may further include
a processor 110, a printer 120 and a communications module 180.
These components may be implemented by any conventional or other
components performing the functions described herein. Processor 110
is coupled to temperature controller 38 and detection circuitry 100
in order to receive information relating to the basin, liquid
temperature, heater temperature and/or drape container conditions.
The processor may receive any additional information (e.g.,
facility information, doctor information, patient information,
solution information, instrument information, case information,
etc.) from medical personnel or users via processor input devices
(not shown). Alternatively, information may be entered by use of
bar codes or Radio Frequency identification (RFID) via a bar code
scanner or RFID reader 215. A bar code or RFID tag may indicate any
desired information and be placed on any suitable items (e.g.,
drape, patient file or folder, patient tag or bracelet, etc.).
Processor 110 may further be coupled to sensors 217 and/or 272 to
detect various conditions. For example, the system may detect
withdrawal of sterile medium from the basin. In this case, sensors
217 may include a weight sensor disposed proximate the basin to
detect a change (e.g., decrease) in weight of the basin, thereby
indicating withdrawal of solution. RFID reader 215 may
alternatively be utilized to detect removal of the sterile medium
from the basin. In this case, the reader is disposed proximate the
basin and utilized in conjunction with an RFID label disposed on a
pitcher or other implement used to remove the sterile medium from
the basin, where the reader detects manipulation (e.g., presence
and absence) of the implement within the basin indicating
withdrawal of sterile medium from the basin. Further, sensors 217
may include an optical sensor disposed within the basin to detect
manipulation (e.g., presence and absence) of the implement within
the basin indicating withdrawal of sterile medium from the
basin.
Moreover, sensors 272 of electrode strip 95 may be in the form of a
proximity or optical sensor to detect manipulation (e.g., presence
and absence) of the implement within the basin indicating removal
of sterile medium, or may be in the form of a Hall effect sensor
and be utilized in conjunction with a magnetic tag disposed on the
implement to detect the implement manipulation within the basin. In
this case, electrodes coupled to the sensor may provide signals to
corresponding pins of circuit board 52, where processors 110 and/or
190 may receive and process the electrode signals to determine
conditions and/or provide the reports. In addition, the signals on
electrodes 92, 94 may be affected by the fluid level in the basin,
where processor 190 may detect the voltage or resistance of these
electrodes (e.g., via circuit paths) to determine the occurrence of
a change in fluid level (e.g., and hence, removal of sterile medium
from the basin). Processor 110 may process this information for the
reports.
Processor 110 further maintains the date, elapsed heating time and
occurrence time of an event or condition (e.g., the time when a
leak occurs, the time when instruments are inserted within the
drape container, withdrawal of solution from the drape container,
etc.). The processor may measure the elapsed time or record an
occurrence time based on signals received from the temperature
controller and/or detection circuitry. For example, the processor
may initiate measurement of a time interval in response to the
detection circuitry indicating solution within the drape container,
and may store the elapsed and/or occurrence time in response to a
leak or other condition. The processor may further measure elapsed
time or record elapsed and/or occurrence time in response to
medical personnel manually entering information on the processor
input devices (e.g., start and stop keys).
The processor collects the appropriate information and arranges the
information into a report. The report may be arranged in any
fashion and include any desired information. Moreover, the report
and/or information may be stored in a database or memory device
(e.g., local memory, removable memory, card, disk, etc.) for later
retrieval. In addition, the processor is coupled to a processor or
system display 35 to display the elapsed (or running) time, report
or any desired information to medical personnel. The information
displayed may be selected via the processor input devices, or the
display may include display controls (e.g., buttons, keys, etc.).
Display 35 may be disposed on the cabinet (FIG. 1) at any desired
location.
The processor is further coupled to printer 120 and communications
module 180 in order to provide information to a user. The printer
basically provides a report in hardcopy form. The processor may
control the printer to produce the report at specified times (e.g.,
termination of heating, at particular times of day, after a
particular quantity of uses, etc.) or in response to requests from
medical personnel via processor input devices (e.g., print key).
The printer may print the report on any desired hardcopy medium.
Preferably, the printer places the information onto a label that is
attached to a medical file. The information may be printed during
or after the solution heating, or be stored on a memory device and
printed at a desired time as described above. The printer may
further provide additional copies of the report in response to user
requests, or a medium automatically creating duplicates may be
utilized (e.g., carbon-less paper, etc.). Cabinet 31 may include a
slot (not shown) to provide the printed report to a user. However,
the slot may be defined at any desired location. Since the cabinet
is under the drape adjacent the non-sterile drape side (e.g., the
cabinet is non-sterile), the printed report is typically retrieved
from the cabinet after completion of the medical procedure (e.g.,
when the drape is discarded) to preserve sterility. The system may
provide a power-off delay to enable printing of reports and/or
labels for a limited time interval after power down of the system
(e.g., actuation of power switch 37).
Communications module 180 enables the report to be provided in
electronic form. This module basically facilitates communication
with other devices for transference or downloading of the report to
those devices. For example, the information may be downloaded or
transmitted over a network or other communications medium to
another device (e.g., PDA, computer, another thermal treatment
system, etc.) for viewing, storage and/or printing. Moreover, the
communications module may facilitate retrieval of information
(e.g., patient information, facility information, doctor
information, solution information, instrument information, etc.)
from a database or other source for the report.
Operation of the thermal treatment system with the present
invention drape is described with reference to FIGS. 1 and 9-11.
Initially, drape 17 is placed over the top surface of the thermal
treatment system and disposed in basin 33 to form a drape
receptacle. Electrode strip 95 of the drape is coupled to
receptacle 49 to connect the drape to the detection circuitry to
facilitate detection of drape container conditions. Power switch 37
is actuated and the detection circuitry detects the presence of an
enabled fuse. Once an enabled fuse is detected, the detection
circuitry disables that fuse to prevent re-use of the drape with
the system and further detects the fuse status to ensure the fuse
has actually been disabled. After the fuse disablement is
confirmed, the detection circuitry senses the absence of solution
and a leak within the drape container in the manner described
above. A corresponding diode may be illuminated to indicate this
condition, while thermal treatment of the basin may be
disabled.
A sterile medium is disposed within the drape receptacle and a
desired temperature for the medium is entered into the system by
the user via controller 38. The sterile medium forms a conductive
path between electrodes 92, 94 that affects the resistance (or
voltage) along a circuit path within the detection circuitry as
described above. The detection circuitry senses the change
indicating the presence of solution without a leak in the drape
container, and may illuminate a corresponding diode. Temperature
controller 38 is subsequently enabled and controls thermal
treatment of the basin.
When a leak occurs within the drape container, the resistance (or
voltage) along the circuit path changes as described above. The
detection circuitry senses the change indicating a leak within the
drape container and may disable thermal treatment of the basin. A
corresponding diode may be illuminated to indicate this condition.
Further, processor 110 may receive information from the temperature
controller, sensors 217, 272 and/or detection circuitry to record
the elapsed and/or occurrence time as described above.
Processor 110 may receive appropriate information for a report from
the temperature controller, sensors 217, 272, detection circuitry
and/or processor input devices at any time (e.g., before, during or
after the heating session). The processor arranges the information
into a desired report as described above. The report may be
produced by printer 120 or transmitted to another device via
communications module 180 as described above. The report may be
generated in response to termination of a session (e.g., indicated
by signals received by processor 110 from the temperature
controller and/or detection circuitry) or a request by medical
personnel (e.g., via processor or other input devices).
It is to be understood that the present invention may be employed
for thermal treatment systems including a plurality of basins that
either heat or cool the sterile medium. An exemplary plural basin
system and corresponding drape according to the present invention
are illustrated in FIG. 13. Specifically, the plural basin system
includes an integral assembly 51 including warming basin 33 and a
substantially circular cooling basin 56 to thermally treat sterile
liquid. The system may alternatively be in the form of an
integrated table top unit (with or without a stand), or separate
individual table top units (with or without a stand) similar to the
unit described above for FIG. 1. The plural basin system includes
power switches 37, 57 and controllers 38, 58 to control operation
of the warming and cooling basins, respectively. The assembly
further houses the heating and refrigeration devices and control
circuitry (not shown) for the individual basins to thermally treat
those basins and liquid contained therein as described above.
A drape 55, substantially similar to drape 17 described above, is
placed over the system and within each basin to form a drape
receptacle therein as described above. Sensing devices 90 are
affixed at appropriate locations on the drape in the manner
described above for insertion within a corresponding basin to
detect drape container conditions within that basin. Electrode
signals are conveyed from each sensing device disposed within a
basin to a corresponding individual condition circuit associated
with that basin to determine drape container conditions and provide
signals to control the basin in substantially the same manner
described above. The assembly may further include a wiring housing
45 associated with each basin to transfer signals between that
housing and a corresponding individual condition circuit in
substantially the same manner described above. Each wiring housing
may include a receptacle 49 to receive a corresponding connector 91
of the associated drape sensing device. Alternatively, the
receptacles may be disposed on a top surface of the assembly
adjacent a corresponding basin in substantially the same manner
described above. Each wiring housing typically includes diodes 147,
149, 151 to indicate drape container conditions within a
corresponding basin. The individual basins each basically function
in substantially the same manner as the single basin system
described above, where the plural basins may be individually
controlled or collectively controlled (e.g., all basins enabled or
disabled) in response to drape container conditions.
It will be appreciated that the embodiments described above and
illustrated in the drawings represent only a few of the many ways
of implementing a system and method of detecting fluid and leaks in
thermal treatment system basins.
The warming, cooling and plural basin systems and their
corresponding cabinets, assemblies or housings may be of any shape
or size and may be constructed of any suitable materials. The
systems may include an integral housing or individual units.
Further, the systems may include a housing for free standing
operation, or be in the form of table or counter top units. The
plural basin system may include any quantity of heating and/or
cooling basins in any combinations. The basins of the systems may
be of any shape or size, may be constructed of any suitable thermal
conducting materials (e.g., stainless steel, etc.) and may be
disposed at any suitable locations on or within the housings. The
systems may include any conventional or other heating and/or
refrigeration units to thermally treat the sterile medium or other
substance to any desired temperature. The heating unit may include
any conventional or other heating device and components to control
heating of a basin to any desired temperature (e.g., preferably to
temperatures near (e.g., above, at or below) body temperature, such
as temperatures in the approximate range of 60.degree.
F.-160.degree. F.). The heater may be of any quantity (e.g., at
least one), shape or size, and may include any configuration (e.g.,
strips, bars, segments, etc.) that covers the entirety or any
portion of a basin. The heater may be attached to a basin via any
conventional or other fastening techniques (e.g., any type of
adhesives, brackets, etc.). In addition, the heater may be
implemented by any conventional or other type of heater or heating
element (e.g., heating coils, etc.) that may be disposed on or
proximate a basin at any suitable locations.
The cooling unit may include any conventional or other cooling or
refrigeration device and components to control cooling of a basin
to any desired temperature (e.g., preferably to temperatures near
or below the freezing temperature of the sterile liquid or medium,
such as temperatures in the approximate range of -32.degree. F. to
32.degree. F.). The various power switches and controllers of the
systems may be implemented by any conventional or other power and
control devices and may be disposed on the systems at any suitable
locations.
The temperature sensor may be implemented by any quantity of any
conventional or other temperature sensing device (e.g., infrared,
RTD, etc.), may be disposed at any location on, within or proximate
a basin or within the systems to measure temperature of any desired
items (e.g., basin, heater or cooler, liquid, etc.). The measured
item temperatures may be utilized for display, reports, system
operational control or any other desired application. The basins of
the systems may be disposed in any arrangement or at any suitable
locations on the systems. The systems may thermally treat (e.g.,
heat or cool) any type of medium or liquid, while a cooling basin
may further include any type of conventional or other dislodgement
mechanism, such as those described in the aforementioned
patents.
The wiring housing may be of any quantity, shape or size, may be
constructed of any suitable materials, and may be disposed at any
suitable locations on the systems. The wiring housing and/or
systems may include any suitable conductors or other medium (e.g.,
wireless, fiberoptics, etc.) to transfer signals between system
components. The wiring housing or system may include any quantity
of any type of receptacle disposed at any suitable location on the
wiring housing or systems to interface the drape. The receptacle
may be of any quantity, shape or size and include any quantity of
receptacles to interface the drape. The receptacles may include any
quantity of any suitable contact (e.g., clamp, terminal, etc.) to
transfer signals with the drape.
The wiring housing may include any quantity of any type of
indicator (e.g., audio, speech synthesis, LED, display screen with
text or images, speaker, etc.) to indicate the drape container
status. The indicator may be disposed on the wiring housing or
systems at any suitable locations. The diodes may be of any
quantity or color, may be disposed at any suitable locations on the
wiring housing or systems and may be illuminated in any desired
fashion or pattern (e.g., flashing, continuous illumination, etc.).
A drape container or other condition may be associated with any
quantity of any diodes of any color (e.g., the same or different
colors in any desired combinations, etc.).
The drape may be of any size or shape, may be constructed of any
suitable materials, and may include any suitable electrical or
other properties (e.g., conductance/resistance, non-conductive,
conductive, etc.) compatible with the sensing device. The drape is
preferably transparent or translucent to facilitate manipulation of
controls through the drape; however, the drapes may have any degree
of transparency (e.g., including opaque). The drape may be
manipulated in any fashion with any portions of the drape serving
as a drape receptacle within a corresponding basin. The drape may
be of sufficient size to accommodate and form drape receptacles
within any quantity of thermal treatment system basins.
The sensing device may include any quantity of electrodes or
electrode strips disposed at any suitable locations on a drape. The
electrodes may be constructed of any suitable conductive materials
(e.g., metallic ink, wires, strips, etc.). The electrode strip may
be of any shape or size, and may be constructed of any suitable
materials. The electrodes may be fastened to the strip at any
suitable locations via any conventional or other fastening
techniques. The strip may include any quantity of any conventional
or other sensors (e.g., temperature, humidity, optical, Hall
effect, magnetic, etc.) to detect any suitable conditions (e.g.,
temperature, fluid level, withdrawal of solution, etc.). The
sensors may be coupled to any quantity of electrodes on the strip
to transfer signals. The pouch may be of any quantity, shape or
size, may be constructed of any suitable materials, may contain any
portions of the electrodes or electrode strip and may be fastened
to the drape at any suitable locations via any conventional or
other fastening techniques. The flap may be of any quantity, shape
or size, may be attached to the drape at any suitable locations via
any conventional or other fastening techniques to form the pouch
and may be constructed of any suitable materials. The seams may be
disposed on the flap at any suitable locations in a continuous or
intermittent fashion to attach the flap to the drape to form the
pouch. The flap may include any quantity of openings or slots of
any shape or size disposed in any suitable locations on the flap or
pouch and arranged in any fashion to enable liquid within the drape
container to contact the electrodes. Alternatively, the sensing
device or electrode strip may be attached to the drape (e.g.,
without the pouch) via patches or any other securing mechanisms
(e.g., adhesives, welding, etc.) to sense drape container
conditions.
The drape opening may be of any quantity, shape or size and may be
defined in the drape at any suitable locations (e.g., drape
portions within the basin, on the top surface, near the controller
or wiring housing, along the cabinet side walls, etc.). The patches
may be of any quantity, shape or size, may be constructed of any
suitable materials and may be disposed at any suitable locations on
the drape. The drape may include any quantity of openings and
corresponding patches disposed on or attached to either or both of
the sterile and non-sterile drape surfaces. Any patch portions may
be attached to the drape, where the bend or fold may be disposed at
any location and the transverse patch sections may extend at any
angle or orientation. Alternatively, the patches may lay flat
against the drape with the strip extending through the patches or
from a peripheral patch edge. Further, any quantity of patches may
be utilized to seal the opening and/or strip, where the patches may
be disposed at any locations relative to the drape opening (e.g.,
same or opposing sides, any angular displacement, etc.) and be
attached to each other and/or the drape.
The patches may be secured or attached to any portions of each
other, any portions of the strip and/or any portions of the drape
(e.g., at any locations, the entirety or any portion thereof, etc.)
via any conventional or other techniques (e.g., adhesives, heat
welding, pressure, etc.). The drape may include any quantity of
sensing devices for a corresponding basin where the sensing device
signals may be combined in any fashion (e.g., at least one device
detecting liquid, combined logically (e.g., AND, OR, etc.), etc.)
to determine occurrence of drape container conditions (e.g.,
solution or leaks present).
The sensing device plug (e.g., rear panel, projection, etc.) may be
of any shape or size and may be constructed of any suitable
materials. The plug may be implemented by any conventional or other
plug or connector where the electrode traces, fuse and/or sensors
may be disposed at any locations on the plug or strip in any
arrangement. Alternatively, the electrode strip or other objects
may traverse a drape peripheral or other edge (e.g., without being
disposed through the drape) to extend between the sterile and
non-sterile drape surfaces. The plug may be received within the
receptacle in any manner enabling transference of signals.
The plug may alternatively include a microprocessor or chip to
process electrode signals and control the thermal treatment system
(e.g., indicators, heater or any other devices). The microprocessor
may generate the appropriate control signals to control basin
thermal devices and various indicators in accordance with the
determined conditions. In addition, the microprocessor may maintain
use information for the drape and indicate prior use to the thermal
treatment system to prevent system operation.
The fuse may be implemented by any type of electrical, mechanical
or other device (e.g., transistor, fuse, switch, relay, optical
device, audio device, electromechanical device, etc.) selectively
controlled to disrupt, disable or alter characteristics of the
electrical or other path (e.g., optical, wired, radio or wireless,
audio, etc.). Alternatively, the fuse may be implemented by any
device accessible by the microprocessor and including plural states
to indicate sterility or prior use of the item (e.g., memory,
optical indicators (e.g., LEDs or other devices with on/off
states), etc.). The fuse may be of any quantity, shape or size, may
include any current and/or voltage thresholds and may be
accompanied by any additional circuitry (e.g., resistors,
capacitors, inductors, switches, transistors, etc.) for a
particular application. The fuse may be constructed of any
materials (e.g., glass fuse, thin painted metallic line, etc.). The
status and disablement signals may be of any quantity or magnitude
sufficient to test the fuse status or disable the fuse (e.g., these
signals may be of any voltage or current types or levels (e.g.,
digital, analog, AC, DC, volts, amps, any fractions of volts or
amps, etc.)). The microprocessor may transmit the status and
disablement signals in any fashion and in response to any desired
conditions or at any desired time intervals (e.g., the status
signals may be sent periodically, the disablement signal may be
transmitted at any desired time interval after transmission of a
status signal, etc.).
Drape container conditions may be determined based on any desired
electrical or other parameters or characteristics (e.g., potential
or voltage, current, resistance, etc.) of any quantity of
electrodes and/or from the sensors coupled thereto. The parameters
may be measured at any suitable locations (e.g., at any locations
along each electrode, between the electrodes, between the
electrodes and basin, at the basin, between the electrodes and
detection circuitry, within the detection circuitry, etc.). In
addition, the presence of the drape may be detected based on the
connection (or lack thereof) of the drape electrodes to the thermal
treatment system (or detection circuitry) to control system
operation (e.g., disable thermal treatment of the basin in the
absence of a drape).
The control circuit may be disposed within the systems at any
suitable locations and may be implemented by any conventional or
other circuitry components arranged in any desired fashion to
perform the described functions. The systems may be powered by any
conventional or other power source (e.g., AC, DC, wall outlet jack,
batteries, etc.). The power supply and other components may be
coupled via any conventional or other connectors for transferring
signals. The power cord may be implemented by any conventional or
other cord or cable and be configured to accommodate any desired
power signals. The thermostat may be implemented by any
conventional switching type or limiting devices, such as a high
limit thermostat, and may be disposed at any suitable location
within the systems.
The detection circuitry may be disposed within the system at any
suitable locations and may include any quantity of conventional or
other components arranged in any desired fashion to perform the
functions described herein. The detection circuitry may utilize any
suitable reference potentials to detect solution, leaks or any
other conditions. The electrical connections may include any
quantity of components (e.g., power cord, fuses, conductors,
connectors, power supply, circuit board, diodes, etc.) arranged in
any desired fashion, where each component may be implemented by any
conventional or other component performing the described function.
The temperature controller may be implemented by any conventional
or other temperature controller and include any desired devices for
entering a temperature (e.g., buttons, keypad, etc.). The
temperature controller may control the heater to any desired
temperature range, and may utilize any quantity of set points
(e.g., maximum and/or minimum, etc.). The basin power switches of
the systems may be implemented by any conventional or other
switching device, while surge fuses may be implemented by any
conventional fuse or other limiting device and may be configured
for any current or voltage levels to protect the circuitry.
The circuit board housing the condition circuit may include any
quantity of terminals or pins each associated with any desired
signals or portion of the condition circuit. The circuit board may
include any quantity of indicators disposed at any suitable
locations to indicate the occurrence or status of any desired
circuit portion or condition. The power supply may be implemented
by any conventional or other power supply or source and provide any
desired power signals, and may include any type of conventional or
other receptacle for receiving any type of plug or connector. The
diodes or other indicators may be connected to the circuit board
pins in any desired fashion. The circuit board may house the
condition circuit and/or any other desired system circuitry.
Further, the circuit board may include devices to record any types
of information relating to system operation for subsequent
retrieval and analysis (e.g., date and time of thermal treatment
disablement and enablement, etc.).
The condition circuit may include any quantity of conventional or
other components arranged in any desired fashion to perform the
functions described herein. The microprocessor may be implemented
by any conventional or other microprocessor or controller. The
comparator may be implemented by any conventional or other
comparators or comparing devices (e.g., hardware and/or software)
and may utilize any suitable reference potentials to detect
solution, leaks or any other conditions. The microprocessor may
produce oscillating outputs (e.g., pulse trains, etc.) at any
desired frequency and drive any type of device (e.g., speaker,
speech synthesis, diode, etc.) to indicate the presence of a
condition, while the indicator devices may alternatively be driven
by any type of circuitry or mechanism. The speaker may be
implemented by any conventional or other speaker or audio device
and may provide any suitable audio indication (e.g., beep at any
suitable periodic interval, continuous audio output, etc.).
The triac may be implemented by any conventional or other triac or
relay type device to provide signals to thermal control circuitry
for controlling thermal treatment of a basin. The condition circuit
may include any conventional or other circuitry (e.g., resistors,
capacitors, inductors, diodes, supply and ground potentials, etc.)
arranged in any fashion and including any desired electrical
characteristic values (e.g., resistance, potential, capacitance,
etc.) to facilitate circuit operation. The condition circuit
signals may include any desired logic or voltage levels. The
optocoupler may be implemented by any conventional or other
optocoupler or other circuitry to control the triac to provide
signals to the thermal control circuitry.
The microprocessor of the detection circuit may employ any suitable
delays (e.g., seconds, minutes, etc.) for disabling and checking
the status of the fuse. The delays may be determined in any
suitable manner (e.g., predetermined, random, based on drape
container or other conditions, etc.). The microprocessor may
further be implemented by or implement the temperature controller
and/or report processor.
The plural basin system may include individual thermal control and
detection circuitry associated with each basin to monitor drape
container conditions and control basin operation. Alternatively,
the plural basin system may include common thermal control and
detection circuitry to control each basin in response to drape
container conditions. The common circuitry may receive signals from
each of the electrodes and control the basins individually or
collectively in response to the drape container conditions. The
common circuitry may process and combine the signals in any fashion
(e.g., AND, OR, etc.) to determine conditions for controlling the
basins.
The control circuitry may include devices to record any types of
information relating to system operation for subsequent retrieval,
analysis, display and reports (e.g., date and time of thermal
treatment disablement and enablement, etc.). The processor may be
implemented by any conventional or other microprocessor or
controller and include any quantity of any desired input devices
(e.g., buttons, keypad, etc.). The processor may receive
information from any suitable devices (e.g., bar code scanner, RFID
reader, etc.) disposed at any suitable locations on or within the
system. The reader/scanner may be implemented by any quantity of
any conventional or other devices, where the bar code, RFID or
other tag may provide any desired information and be disposed at
any suitable locations on the patient or an article (e.g., label,
patient chart, patient garment, equipment, etc.). The processor may
maintain the date, elapsed heating time and/or occurrence time of
any event or condition (e.g., time when a leak occurs, time
instruments inserted within drape container, etc.). The processor
may measure the elapsed time or record an occurrence time for any
desired condition. The processor may maintain the time information
internally or utilize any desired external circuitry (e.g., a
timer, etc.).
The processor may collect any desired information (e.g., start date
and time of solution heating, the time interval the solution was
heated, the temperature the solution attained during heating,
partial or complete history of time and solution temperature
measured at any desired time intervals, facility name and location,
patient information, doctor information, type of procedure, type of
solution and/or instruments being heated, amount of solution being
heated, etc.) from any desired sources (e.g., detection circuitry,
temperature controller, user, memory device, another computer or
device, sensors, etc.). The sensors may be of any quantity or type
(e.g., weight, optical, magnetic, etc.) and may be disposed within
the cabinet at any suitable locations to measure any desired
conditions (e.g., withdrawal of solution, solution temperature,
etc.).
The reports may be arranged in any fashion and include any desired
information. The report information may be arranged and/or
presented (e.g., printed, displayed, etc.) in any desired formats
(e.g., text, charts, graphs, etc.). The report and/or information
may alternatively be stored in a local or remote database or memory
device (e.g., local memory, removable memory, etc.) for later
retrieval. The reports may include a pre-arranged format or may be
programmable or selected by a user via processor input devices. The
system, controller and processor displays may be of any quantity,
shape or size, may be disposed at any location on and/or within the
system (e.g., cabinet, wiring housing, etc.) or remote from the
system, may be implemented by any conventional or other displays
(e.g., LED, LCD, etc.) and may display any desired information. The
information displayed may be selected via controller or processor
input devices, or the display may include display controls (e.g.,
buttons, keys, etc.).
The printer may be implemented by any conventional or other
printing device, may be local or remote, may serve any quantity of
systems or other devices, and may produce reports on any desired
medium (e.g., paper, labels, etc.). The reports may be printed at
any specific time or in response to user entered information (e.g.,
a print command or key). The printer slot may be of any quantity,
shape or size and may be disposed at any suitable location on the
cabinet and/or wiring housing. The report may be printed at any
desired time before, during or after system use, and may be
retrieved from the system at any desired time or in any desired
manner that preserves a sterile field (e.g., after completion of
the medical procedure, after discarding the drape, times when a
sterile field is not needed or being employed by the system, etc.).
The power-off delay may be set to any desired interval (e.g., one
minute, five minutes, etc.) and may enable use of any system
components during that interval subsequent power down of the
system.
The communications module may be implemented by any conventional or
other communications device or module (e.g., modem, etc.) and may
download or transfer an electronic form of the report to any
desired device (e.g., PDA, computer, another thermal treatment or
other system, etc.) at any specific time or in response to user
entered information (e.g., transmit command or key). The systems
may further be networked to enable retrieval of reports and/or
information from a station coupled to the network. The printer and
communications module may be disposed at any suitable locations on
or within the system (e.g., on or within the cabinet, wiring
housing, etc.) or remote from the system. Any desired information
may be transmitted between the control circuitry components (e.g.,
temperature controller, detection circuitry, processor, printer,
communications module, displays, etc.) via any conventional or
other communications medium or protocols (e.g., hardwire, wireless,
network, etc.). The processor may implement or be implemented by
the temperature controller. The various sensors (e.g., temperature
sensor 72, sensors 217, 272, etc.) may be coupled to the
temperature controller, microprocessor and/or processor either
individually or in any combination or fashion.
software for the temperature controller, plug microprocessor,
detection circuit microprocessor for processing the electrode
signals and report processor may be implemented in any desired
computer language and could be developed by one of ordinary skill
in the computer arts based on the functional descriptions contained
herein. The controller, microprocessors and/or processor may
alternatively be implemented by any type of hardware and/or other
processing circuitry, and may be available pre-programmed for
immediate use. The various functions of the controller,
microprocessors and/or processor may be distributed in any manner
among any quantity of software modules, processors and/or
circuitry. The software, algorithms and/or processes described
above and illustrated in the flow chart and diagrams may be
modified in any manner and/or may perform operations in any order
that accomplishes the functions described herein.
It is to be understood that the terms "top", "bottom", "front",
"rear", "side", "height", "length", "width", "upper", "lower" and
the like are used herein merely to describe points of reference and
do not limit the present invention to any particular orientation or
configuration.
From the foregoing description, it will be appreciated that the
invention makes available a novel system and method of detecting
fluid and leaks in thermal treatment system basins, wherein a
surgical drape includes a sensing device with a fuse to prevent
re-use of the drape and to provide signals indicating drape
container conditions to a thermal treatment system to facilitate
control of system operation.
Having described preferred embodiments of a new and improved system
and method of detecting fluid and leaks in thermal treatment system
basins, it is believed that other modifications, variations and
changes will be suggested to those skilled in the art in view of
the teachings set forth herein. It is therefore to be understood
that all such variations, modifications and changes are believed to
fall within the scope of the present invention as defined by the
appended claims.
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